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Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Primary Purpose

Scleroderma, Gastroparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcutaneous electroacupuncture
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma focused on measuring transcutaneous electroacupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No any systemic diseases;
  • no scleroderma; no history of gastrointestinal surgery;
  • no dyspeptic symptoms during the past 2 weeks;
  • not taking any medications except contraceptives during the past 2 weeks;
  • age 18 and older.

Exclusion Criteria:

  • History of any systemic diseases or surgeries;
  • allergic to adhesives; pregnancy;
  • unable to sign the consent form.

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

scleroderma patients-0

scleroderma patient-1

scleroderma patients-2

Arm Description

for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).

for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.

for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.

Outcomes

Primary Outcome Measures

effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms

Secondary Outcome Measures

effects of TEA on gastric motility
visit 1 in acute phase; gastric slow waves recording
effects of TEA on gastric motility
visit 2 in acute phase; gastric slow waves recording
effects of TEA on gastric motility
visit 3 in acute phase; gastric slow waves recording
effects of TEA on gastric motility
visit 4 in acute phase; gastric slow waves recording
effects of TEA on autonomic function
visit 1 in acute phase; heart rate variability recording
effects of TEA on autonomic function
visit 2 in acute phase; heart rate variability recording
effects of TEA on autonomic function
visit 3 in acute phase; heart rate variability recording
effects of TEA on autonomic function
visit 4 in acute phase; heart rate variability recording
effects of TEA on gastric motility
visit 1 in chronic phase; gastric slow waves recording
effects of TEA on gastric motility
visit 2 in chronic phase; gastric slow waves recording
effects of TEA on gastric motility
visit 3 in chronic phase; gastric slow waves recording
effects of TEA on gastric motility
visit 4 in chronic phase; gastric slow waves recording
effects of TEA on gastric motility
visit 1 in chronic phase; breath test will be used to assess gastric emptying
effects of TEA on gastric motility
visit 2 in chronic phase; breath test will be used to assess gastric emptying
effects of TEA on gastric motility
visit 3 in chronic phase; breath test will be used to assess gastric emptying
effects of TEA on gastric motility
visit 4 in chronic phase; breath test will be used to assess gastric emptying
effects of TEA on autonomic function
visit 1 in chronic phase; heart rate variability recording
effects of TEA on autonomic function
visit 2 in chronic phase; heart rate variability recording
effects of TEA on autonomic function
visit 3 in chronic phase; heart rate variability recording
effects of TEA on autonomic function
visit 4 in chronic phase; heart rate variability recording
effects of TEA on autonomic function
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
effects of TEA on autonomic function
visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
effects of TEA on autonomic function
visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
effects of TEA on autonomic function
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

Full Information

First Posted
August 18, 2017
Last Updated
November 22, 2019
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03294616
Brief Title
Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
Official Title
Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Gastroparesis
Keywords
transcutaneous electroacupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
scleroderma patients-0
Arm Type
Experimental
Arm Description
for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).
Arm Title
scleroderma patient-1
Arm Type
Experimental
Arm Description
for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
Arm Title
scleroderma patients-2
Arm Type
Experimental
Arm Description
for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
Intervention Type
Device
Intervention Name(s)
transcutaneous electroacupuncture
Other Intervention Name(s)
TEA
Intervention Description
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Primary Outcome Measure Information:
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
Time Frame
1 day
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
Time Frame
28 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
Time Frame
42 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
Time Frame
70 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time Frame
1 day
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time Frame
28 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time Frame
42 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time Frame
70 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
SF-36 questionnaire will be used to assess general quality of life
Time Frame
1 day
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
SF-36 questionnaire will be used to assess general quality of life
Time Frame
28 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
SF-36 questionnaire will be used to assess general quality of life
Time Frame
42 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
SF-36 questionnaire will be used to assess general quality of life
Time Frame
70 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
a validated method including 9 symptoms will be used to assess GI symptoms
Time Frame
1 day
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
a validated method including 9 symptoms will be used to assess GI symptoms
Time Frame
28 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
a validated method including 9 symptoms will be used to assess GI symptoms
Time Frame
42 days
Title
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Description
a validated method including 9 symptoms will be used to assess GI symptoms
Time Frame
70 days
Secondary Outcome Measure Information:
Title
effects of TEA on gastric motility
Description
visit 1 in acute phase; gastric slow waves recording
Time Frame
1 week
Title
effects of TEA on gastric motility
Description
visit 2 in acute phase; gastric slow waves recording
Time Frame
2 weeks
Title
effects of TEA on gastric motility
Description
visit 3 in acute phase; gastric slow waves recording
Time Frame
3 weeks
Title
effects of TEA on gastric motility
Description
visit 4 in acute phase; gastric slow waves recording
Time Frame
4 weeks
Title
effects of TEA on autonomic function
Description
visit 1 in acute phase; heart rate variability recording
Time Frame
1 week
Title
effects of TEA on autonomic function
Description
visit 2 in acute phase; heart rate variability recording
Time Frame
2 weeks
Title
effects of TEA on autonomic function
Description
visit 3 in acute phase; heart rate variability recording
Time Frame
3 weeks
Title
effects of TEA on autonomic function
Description
visit 4 in acute phase; heart rate variability recording
Time Frame
4 weeks
Title
effects of TEA on gastric motility
Description
visit 1 in chronic phase; gastric slow waves recording
Time Frame
1 day
Title
effects of TEA on gastric motility
Description
visit 2 in chronic phase; gastric slow waves recording
Time Frame
28 days
Title
effects of TEA on gastric motility
Description
visit 3 in chronic phase; gastric slow waves recording
Time Frame
42 days
Title
effects of TEA on gastric motility
Description
visit 4 in chronic phase; gastric slow waves recording
Time Frame
70 days
Title
effects of TEA on gastric motility
Description
visit 1 in chronic phase; breath test will be used to assess gastric emptying
Time Frame
1 day
Title
effects of TEA on gastric motility
Description
visit 2 in chronic phase; breath test will be used to assess gastric emptying
Time Frame
28 days
Title
effects of TEA on gastric motility
Description
visit 3 in chronic phase; breath test will be used to assess gastric emptying
Time Frame
42 days
Title
effects of TEA on gastric motility
Description
visit 4 in chronic phase; breath test will be used to assess gastric emptying
Time Frame
70 days
Title
effects of TEA on autonomic function
Description
visit 1 in chronic phase; heart rate variability recording
Time Frame
1 day
Title
effects of TEA on autonomic function
Description
visit 2 in chronic phase; heart rate variability recording
Time Frame
28 days
Title
effects of TEA on autonomic function
Description
visit 3 in chronic phase; heart rate variability recording
Time Frame
42 days
Title
effects of TEA on autonomic function
Description
visit 4 in chronic phase; heart rate variability recording
Time Frame
70 days
Title
effects of TEA on autonomic function
Description
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Time Frame
1 day
Title
effects of TEA on autonomic function
Description
visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Time Frame
28 days
Title
effects of TEA on autonomic function
Description
visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Time Frame
42 days
Title
effects of TEA on autonomic function
Description
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function
Time Frame
70 days
Title
effects of TEA on autonomic function
Description
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
1 day
Title
effects of TEA on autonomic function
Description
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
28 days
Title
effects of TEA on autonomic function
Description
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
42 days
Title
effects of TEA on autonomic function
Description
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
70 days
Title
effects of TEA on autonomic function
Description
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
1 day
Title
effects of TEA on autonomic function
Description
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
28 days
Title
effects of TEA on autonomic function
Description
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
42 days
Title
effects of TEA on autonomic function
Description
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
70 days
Title
effects of TEA on autonomic function
Description
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
1 day
Title
effects of TEA on autonomic function
Description
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
28 days
Title
effects of TEA on autonomic function
Description
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
42 days
Title
effects of TEA on autonomic function
Description
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time Frame
70 days
Title
effects of TEA on autonomic function
Description
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
1 day
Title
effects of TEA on autonomic function
Description
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
28 days
Title
effects of TEA on autonomic function
Description
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
42 days
Title
effects of TEA on autonomic function
Description
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
70 days
Title
effects of TEA on autonomic function
Description
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
1 day
Title
effects of TEA on autonomic function
Description
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
28 days
Title
effects of TEA on autonomic function
Description
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
42 days
Title
effects of TEA on autonomic function
Description
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
70 days
Title
effects of TEA on autonomic function
Description
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
1 day
Title
effects of TEA on autonomic function
Description
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
28 days
Title
effects of TEA on autonomic function
Description
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
42 days
Title
effects of TEA on autonomic function
Description
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; vasoactive intestinal peptide (VIP)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; vasoactive intestinal peptide (VIP)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; vasoactive intestinal peptide (VIP)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; vasoactive intestinal peptide (VIP)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-10 (IL-10)
Time Frame
day 1
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-10 (IL-10)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-10 (IL-10)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-10 (IL-10)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-10 (IL-10)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-10 (IL-10)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-10 (IL-10)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-10 (IL-10)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-10 (IL-10)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-10 (IL-10)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-10 (IL-10)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-10 (IL-10)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interferon α(IFNα)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interferon α(IFNα)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interferon α(IFNα)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interferon α(IFNα)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interferon α(IFNα)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interferon α(IFNα)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interferon α(IFNα)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interferon α(IFNα)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interferon α(IFNα)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interferon α(IFNα)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interferon α(IFNα)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interferon α(IFNα)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-1 beta (IL-1β)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-1 beta (IL-1β)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-1 beta (IL-1β)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-1 beta (IL-1β)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-6 (IL-6)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-6 (IL-6)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-6 (IL-6)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; interleukin-6 (IL-6)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-6 (IL-6)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-6 (IL-6)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-6 (IL-6)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; interleukin-6 (IL-6)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-6 (IL-6)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-6 (IL-6)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-6 (IL-6)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; interleukin-6 (IL-6)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; tumor necrosis factor alpha(TNFα)
Time Frame
day 1
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; tumor necrosis factor alpha(TNFα)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; tumor necrosis factor alpha(TNFα)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
baseline before the study; tumor necrosis factor alpha(TNFα)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time Frame
70 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time Frame
1 day
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time Frame
28 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time Frame
42 days
Title
effects of TEA on GI hormones and inflammatory cytokine
Description
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time Frame
70 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No any systemic diseases; no scleroderma; no history of gastrointestinal surgery; no dyspeptic symptoms during the past 2 weeks; not taking any medications except contraceptives during the past 2 weeks; age 18 and older. Exclusion Criteria: History of any systemic diseases or surgeries; allergic to adhesives; pregnancy; unable to sign the consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiande Chen, Ph.D
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
haven't decided yet.

Learn more about this trial

Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

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