Clinical trial NCT03440255: 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
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Chronic Pain
Irritable Bowel Syndrome
Keywords: Transcutaneous Vagus nerve Stimulation
Generalized Anxiety Disorder
Chronic Pain
Irritable Bowel Syndrome
Private Practice
Lead sponsor: Kinesis Health Associates
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline generalized anxiety disorder severity
timeFrame: baseline, 4-week and 2-month follow-up
measure: Change from baseline pain severity and pain interference
timeFrame: baseline, 4-week and 2-month follow-up
measure: Change from baseline irritable bowels syndrome severity
timeFrame: baseline, 4-week and 2-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Dartmouth
country: Canada
facility: Kinesis Health Associates
state: Nova Scotia
Study officials:
name: Pascal JD Grolaux, DO
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.