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Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation

Primary Purpose

Functional Gastrointestinal Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TENS Unit
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female 12 - 18 years old Either diagnosed OR not diagnosed with chronic idiopathic nausea, functional abdominal pain, dyspepsia and/or irritable bowel syndrome. English speaking Exclusion Criteria: Patients who are unable to stand upright during the heart rate variability recording Patients with a known bleeding disorder Patients with swollen, infected, inflamed, or other skin eruptions on outer ear Patients with epilepsy Patients with any implanted cardiac pacemaker or defibrillator Patients with serious arterial circulatory problems in the lower limbs Patients with abdominal or inguinal hernia Patients who are pregnant Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc. Requires new medication during the 4 weeks of the study that may affect the gastrointestinal symptoms, vagal modulation or immune response. Practices over 1 hour of aerobic activity a day Daily practice of abdominal breathing (yoga)

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FGID

Non-FGID

Arm Description

Patients with a FGID

Patients without a FGID

Outcomes

Primary Outcome Measures

Change in high-frequency heart rate variability (hfHRV) at 4 weeks
Determine if microstimulation to the conchae of the ear over a 4 week period results in improvement in hfHRV.
Change in high-frequency heart rate variability (hfHRV) after 4 weeks of TENS use Determine if 4 hours/day of microstimulation increases hfHRV more significantly than 2 hours/day over a 4-week period
Determine if 4 hours/day of microstimulation increases hfHRV more significantly than 2 hours/day over a 4-week period
Rate of feasibility with daily TENS usage
Determine the feasibility of utilizing a microstimulator in adolescents.
Rate of compliance with daily TENS usage
Determine the compliance rate of adolescents utilizing a microstimulator.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2023
Last Updated
October 19, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05987813
Brief Title
Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation
Official Title
A Pilot Study of Randomized Auricular Microstimulation to Determine if it Improves Vagal Modulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to determine if the auricular microstimulator produces the expected increase in HRV.
Detailed Description
The aim of this proposal is to determine if utilizing an affordable tool like microstimulation utilizing a transcutaneous electric nerve stimulator (TENS) unit and applying the stimulation to the ear though an ear clip does improve vagal modulation. This can be easily done at home by utilizing the microstimulation for 2 or 4 hours/day and measuring vagal modulation before and after. Previous research investigating this had participants use the unit for 2 hours. (Chelimsky et al., 2019). The data from this study was inconclusive, and by adding the 4 hour condition, this project can investigate if the inconclusive data was due to poor compliance or the need for a longer duration of use to improve vagal modulation. Although functional gastrointestinal disorders (FGID) affect 10%-20% of children and adolescents. 1-3 the pathophysiology remains unknown. The multiple current hypotheses include visceral hypersensitivity, altered brain-gut connections, dysbiosis, genetic and epigenetic factors, and increased gut permeability among others. 4 Since the vagus nerve links the brain to the gut, many studies of adult subjects have evaluated the cardiovagal modulation in this group of disorders. The cardiovagal modulation can be measured by heart rate variability (HRV). HRV evaluates the heart rate fluctuation over a period of time. HRV is considered a reliable tool to look at parasympathetic function, baroreflex function, and parasympathetic to sympathetic balance.5, 6 High-frequency (hf) HRV is a marker of vagal modulation. The low-frequency (lf) HRV probably reflects cardiac autonomic outflow from the baroreflex or parasympathetic regulation, rather than sympathetic modulation, although this is still being discussed.6, 7 A meta-analysis of adult subjects with irritable bowel syndrome (IBS) showed decreased cardiovagal modulation.8 One study compared children aged 7-10 years of age with functional abdominal pain or IBS to healthy subjects. They found no difference in cardiovagal and cardiac sympathetic modulation.9 However, a study of young adolescents with different chronic pain syndromes, including chronic abdominal pain, showed decreased cardiovagal modulation.10 These findings are similar to those in many adult syndromes with chronic pain, such as chronic pelvic pain,11 complex regional pain syndrome,12 fibromyalgia,13 and chronic neck pain.14 Although future research would aim to investigate vagal modulation in those specifically with FGID, for preliminary data purposes we are testing the unit's effects on heart rate variability regardless of having/not having an FGID diagnosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
FGID group, non-FGID group. Randomized to 2 or 4 hours of daily TENS usage
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FGID
Arm Type
Experimental
Arm Description
Patients with a FGID
Arm Title
Non-FGID
Arm Type
Experimental
Arm Description
Patients without a FGID
Intervention Type
Device
Intervention Name(s)
TENS Unit
Intervention Description
Usage of the Transcutaneous Electrical Nerve Stimulation device for either 2 or 4 hours a day depending on randomization.
Primary Outcome Measure Information:
Title
Change in high-frequency heart rate variability (hfHRV) at 4 weeks
Description
Determine if microstimulation to the conchae of the ear over a 4 week period results in improvement in hfHRV.
Time Frame
Assessed at baseline and 4 weeks.
Title
Change in high-frequency heart rate variability (hfHRV) after 4 weeks of TENS use Determine if 4 hours/day of microstimulation increases hfHRV more significantly than 2 hours/day over a 4-week period
Description
Determine if 4 hours/day of microstimulation increases hfHRV more significantly than 2 hours/day over a 4-week period
Time Frame
Assessed at baseline and 4 weeks.
Title
Rate of feasibility with daily TENS usage
Description
Determine the feasibility of utilizing a microstimulator in adolescents.
Time Frame
Assessed daily for duration of study (4 weeks) via self-report recording journal.
Title
Rate of compliance with daily TENS usage
Description
Determine the compliance rate of adolescents utilizing a microstimulator.
Time Frame
Assessed daily for duration of study (4 weeks) via self-report recording journal.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female 12 - 18 years old Either diagnosed OR not diagnosed with chronic idiopathic nausea, functional abdominal pain, dyspepsia and/or irritable bowel syndrome. English speaking Exclusion Criteria: Patients who are unable to stand upright during the heart rate variability recording Patients with a known bleeding disorder Patients with swollen, infected, inflamed, or other skin eruptions on outer ear Patients with epilepsy Patients with any implanted cardiac pacemaker or defibrillator Patients with serious arterial circulatory problems in the lower limbs Patients with abdominal or inguinal hernia Patients who are pregnant Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc. Requires new medication during the 4 weeks of the study that may affect the gastrointestinal symptoms, vagal modulation or immune response. Practices over 1 hour of aerobic activity a day Daily practice of abdominal breathing (yoga)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madison Maxwell, BS
Phone
8048280290
Email
madison.maxwell@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisela Chelimsky, MD
Organizational Affiliation
VCU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madison Maxwell, BS
Phone
540-550-8549
Email
madison.maxwell@vcuhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Anonymized information may be shared to other researchers for future relevant projects.
Citations:
PubMed Identifier
10776953
Citation
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Citation
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Citation
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PubMed Identifier
21890520
Citation
Goldstein DS, Bentho O, Park MY, Sharabi Y. Low-frequency power of heart rate variability is not a measure of cardiac sympathetic tone but may be a measure of modulation of cardiac autonomic outflows by baroreflexes. Exp Physiol. 2011 Dec;96(12):1255-61. doi: 10.1113/expphysiol.2010.056259. Epub 2011 Sep 2.
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Citation
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Citation
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Citation
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Citation
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Citation
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Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation

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