Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center

Study Overview
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Brief Summary
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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
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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).

Official Title
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Transcutaneous Vagus Nerve Stimulation (TaVNS) in Private Healthcare Center: An Open-Label, Non-Randomized Feasibility Study Targeting Anxiety, Chronic Pain and Irritable Bowel Syndrome

Conditions
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Generalized Anxiety Disorder, Chronic Pain, Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Transcutaneous Vagus Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous Vagus Nerve Stimulation<br>TaVNS 8 sessions, 30 min, 4 weeks GAD: 20 Hertz (Hz) - 80 microseconds (µs) CP: 5Hz-200µs IBS: 3Hz-250µs | Device: Transcutaneous Vagus Nerve Stimulation<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 4-week and 2-month follow-up | 
| 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. | baseline, 4-week and 2-month follow-up | 
| 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. | baseline, 4-week and 2-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous Vagus nerve Stimulation, Generalized Anxiety Disorder, Chronic Pain, Irritable Bowel Syndrome, Private Practice