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Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center

Primary Purpose

Generalized Anxiety Disorder, Chronic Pain, Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcutaneous Vagus Nerve Stimulation
Sponsored by
Kinesis Health Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Transcutaneous Vagus nerve Stimulation, Generalized Anxiety Disorder, Chronic Pain, Irritable Bowel Syndrome, Private Practice

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age range 20-65 years old
  2. Patient suffering from either Generalized Anxiety Disorder, Chronic Pain scoring and Irritable Bowel Syndrome from moderate
  3. Patients meet the scoring standard questionnaires: mild to severe
  4. Patient can understand and answer the questions
  5. Patient exhibits symptoms for at least six months

Exclusion Criteria:

  1. Reading difficulties
  2. Diagnosed left ear lesion
  3. Measured blood pressure under 100/60 with or without anti-high blood pressure medicine
  4. Active implant such as cochlear implant
  5. Wounds and skin disease in the left ear
  6. Recent head trauma or concussion
  7. Cardiac pacemaker
  8. Severe alcoholism
  9. Left cervical vagotomy
  10. Cholinergic or B blocking medicine
  11. Recreative drugs
  12. Diagnosed concomitant psychiatric comorbidity
  13. Diagnosed concomitant personal disorders
  14. Diagnosed pregnancy
  15. Diagnosed concomitant severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic infectious diseases uncompensated

Sites / Locations

  • Kinesis Health Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcutaneous Vagus Nerve Stimulation

Arm Description

TaVNS 8 sessions, 30 min, 4 weeks GAD: 20 Hertz (Hz) - 80 microseconds (µs) CP: 5Hz-200µs IBS: 3Hz-250µs

Outcomes

Primary Outcome Measures

Change from baseline generalized anxiety disorder severity
To assess the response effect of the TaVNS on the severity of anxiety disorders measured by the 21 items self-administered Generalized Anxiety Disorder GAD-7 questionnaire, where scoring scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety. A response will be considered as a reduced cut-off point from baseline.
Change from baseline pain severity and pain interference
To assess the response effect of the TaVNS on the severity of pain and the impact of this pain on daily functioning (Interference) measured by the 9 items self-administered Brief Pain Inventory (Short Form) questionnaire; from 0 (no pain) to 10 (worst pain), ratings from 1 to 4 corresponded to mild pain, 5 to 6 to moderate pain, and 7 to 10 to severe pain with cut-off points being 4 and 6. Scoring pain severity is the mean of the total pain score out of 10. Interference from 0 (no interference) to 10 (completely interferes), rating mild (<=5), moderate (6-7), and severe (>= 8) with cut-off points being 5 and 7. Scoring the interference severity is the mean of the total Interference score out of 10. A response will be considered as a reduced cut-off point from baseline.
Change from baseline irritable bowels syndrome severity
To assess the response effect of the TaVNS on the severity of irritable bowel syndrome measured by the self-administered Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), where the maximum achievable score is 500. Mild, moderate and severe categories were indicated by scores of 75 to 175, 175 to 300 and > 300 respectively, with cut-off points being 175 and 300. A response will be considered as a reduced cut-off point from baseline.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2018
Last Updated
February 20, 2018
Sponsor
Kinesis Health Associates
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1. Study Identification

Unique Protocol Identification Number
NCT03440255
Brief Title
Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center
Official Title
Transcutaneous Vagus Nerve Stimulation (TaVNS) in Private Healthcare Center: An Open-Label, Non-Randomized Feasibility Study Targeting Anxiety, Chronic Pain and Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kinesis Health Associates

4. Oversight

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

5. Study Description

Brief Summary
This non-randomized, open-label study has the objective to study the effects and feasibility of Transauricular Vagus Nerve Stimulation (TaVNS) for patients suffering from Generalized Anxiety Disorder (GAD), Chronic Pain (CP) and Irritable Bowel Syndrome (IBS) in a private healthcare centre.
Detailed Description
The effects of TaVNS on GAD, CP and IBS. Participants were investigated during a 4-week period and a 2-month follow-up. Groups (GAD, CP, IBS) were assessed using questionnaires: Anxiety (Generalized Anxiety Disorder GAD-7); CP (Brief Pain Inventory Short Form Questionnaire) and IBS (Irritable Bowel Syndrome Severity Scoring System). TaVNS was performed using a standard transcutaneous electrical nerve stimulation (TENS) device and ear clip electrodes plugged into the concha area of the left ear. All participants received a bi-weekly 30 minutes stimulation (8 sessions). We defined three different TaVNS parameters for each group in hertz (Hz) and microsecond (µs), (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Chronic Pain, Irritable Bowel Syndrome
Keywords
Transcutaneous Vagus nerve Stimulation, Generalized Anxiety Disorder, Chronic Pain, Irritable Bowel Syndrome, Private Practice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Vagus Nerve Stimulation
Arm Type
Experimental
Arm Description
TaVNS 8 sessions, 30 min, 4 weeks GAD: 20 Hertz (Hz) - 80 microseconds (µs) CP: 5Hz-200µs IBS: 3Hz-250µs
Intervention Type
Device
Intervention Name(s)
Transcutaneous Vagus Nerve Stimulation
Intervention Description
TaVNS will be applied by the TENS 7000 device. The stimulation was set according the group of treatment: (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs). The current intensity was individually established under the pain threshold .The stimulus generates an continous asymmetric biphasic waveform. Ear clip electrodes were plugged in the concha area of the left ear. The stimulation will last 30 min per session (total=8)
Primary Outcome Measure Information:
Title
Change from baseline generalized anxiety disorder severity
Description
To assess the response effect of the TaVNS on the severity of anxiety disorders measured by the 21 items self-administered Generalized Anxiety Disorder GAD-7 questionnaire, where scoring scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety. A response will be considered as a reduced cut-off point from baseline.
Time Frame
baseline, 4-week and 2-month follow-up
Title
Change from baseline pain severity and pain interference
Description
To assess the response effect of the TaVNS on the severity of pain and the impact of this pain on daily functioning (Interference) measured by the 9 items self-administered Brief Pain Inventory (Short Form) questionnaire; from 0 (no pain) to 10 (worst pain), ratings from 1 to 4 corresponded to mild pain, 5 to 6 to moderate pain, and 7 to 10 to severe pain with cut-off points being 4 and 6. Scoring pain severity is the mean of the total pain score out of 10. Interference from 0 (no interference) to 10 (completely interferes), rating mild (<=5), moderate (6-7), and severe (>= 8) with cut-off points being 5 and 7. Scoring the interference severity is the mean of the total Interference score out of 10. A response will be considered as a reduced cut-off point from baseline.
Time Frame
baseline, 4-week and 2-month follow-up
Title
Change from baseline irritable bowels syndrome severity
Description
To assess the response effect of the TaVNS on the severity of irritable bowel syndrome measured by the self-administered Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), where the maximum achievable score is 500. Mild, moderate and severe categories were indicated by scores of 75 to 175, 175 to 300 and > 300 respectively, with cut-off points being 175 and 300. A response will be considered as a reduced cut-off point from baseline.
Time Frame
baseline, 4-week and 2-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range 20-65 years old Patient suffering from either Generalized Anxiety Disorder, Chronic Pain scoring and Irritable Bowel Syndrome from moderate Patients meet the scoring standard questionnaires: mild to severe Patient can understand and answer the questions Patient exhibits symptoms for at least six months Exclusion Criteria: Reading difficulties Diagnosed left ear lesion Measured blood pressure under 100/60 with or without anti-high blood pressure medicine Active implant such as cochlear implant Wounds and skin disease in the left ear Recent head trauma or concussion Cardiac pacemaker Severe alcoholism Left cervical vagotomy Cholinergic or B blocking medicine Recreative drugs Diagnosed concomitant psychiatric comorbidity Diagnosed concomitant personal disorders Diagnosed pregnancy Diagnosed concomitant severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic infectious diseases uncompensated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal JD Grolaux, DO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinesis Health Associates
City
Dartmouth
State/Province
Nova Scotia
ZIP/Postal Code
B2Y 1C9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22814704
Citation
Salim S, Chugh G, Asghar M. Inflammation in anxiety. Adv Protein Chem Struct Biol. 2012;88:1-25. doi: 10.1016/B978-0-12-398314-5.00001-5.
Results Reference
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PubMed Identifier
23360102
Citation
Bonaz B, Picq C, Sinniger V, Mayol JF, Clarencon D. Vagus nerve stimulation: from epilepsy to the cholinergic anti-inflammatory pathway. Neurogastroenterol Motil. 2013 Mar;25(3):208-21. doi: 10.1111/nmo.12076. Epub 2013 Jan 29.
Results Reference
background
PubMed Identifier
11903103
Citation
Nagarajan L, Walsh P, Gregory P, Lee M. VNS therapy in clinical practice in children with refractory epilepsy. Acta Neurol Scand. 2002 Jan;105(1):13-7. doi: 10.1034/j.1600-0404.2002.00129.x.
Results Reference
background
PubMed Identifier
26580212
Citation
Trevizol AP, Taiar I, Barros MD, Liquidatto B, Cordeiro Q, Shiozawa P. Transcutaneous vagus nerve stimulation (tVNS) protocol for the treatment of major depressive disorder: A case study assessing the auricular branch of the vagus nerve. Epilepsy Behav. 2015 Dec;53:166-7. doi: 10.1016/j.yebeh.2015.10.002. Epub 2015 Nov 12. No abstract available.
Results Reference
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PubMed Identifier
22568773
Citation
Napadow V, Edwards RR, Cahalan CM, Mensing G, Greenbaum S, Valovska A, Li A, Kim J, Maeda Y, Park K, Wasan AD. Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation. Pain Med. 2012 Jun;13(6):777-89. doi: 10.1111/j.1526-4637.2012.01385.x. Epub 2012 May 8.
Results Reference
background
PubMed Identifier
29163522
Citation
Bonaz B, Sinniger V, Pellissier S. The Vagus Nerve in the Neuro-Immune Axis: Implications in the Pathology of the Gastrointestinal Tract. Front Immunol. 2017 Nov 2;8:1452. doi: 10.3389/fimmu.2017.01452. eCollection 2017.
Results Reference
background
PubMed Identifier
20633378
Citation
George MS, Ward HE Jr, Ninan PT, Pollack M, Nahas Z, Anderson B, Kose S, Howland RH, Goodman WK, Ballenger JC. A pilot study of vagus nerve stimulation (VNS) for treatment-resistant anxiety disorders. Brain Stimul. 2008 Apr;1(2):112-21. doi: 10.1016/j.brs.2008.02.001. Epub 2008 Mar 28.
Results Reference
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Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center

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