Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome

Study Overview
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Brief Summary
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This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life. The safety of the electrical stimulation of the left vagal nerve will also be evaluated. Ten women, age between 18 and 60, will be included.

Official Title
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Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Trans-cutaneous vagal nerve electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged 18-60, clinical Rome III criteria for IBS Exclusion Criteria: pregnancy, low intensity symptoms (Francis score between 75-150) IBD, coeliac disease past history of abdominal surgery (appendectomy and cholecystectomy allowed) chronic use of analgesics, anti-depressants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

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: Vagal nerve stimulation<br>Trans-cutaneous vagal nerve electrical stimulation during 6 months | Device: Trans-cutaneous vagal nerve electrical stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS) |  | 3 and 6 months after the beginning of electrical stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerance of trans-cutaneous nerve stimulation as measured by any symptom occurring in relation with electrical stimulation, number of hours per day of system use | Any symptom occurring in relation with electrical stimulation, number of hours per day of system use | 6 months | 
| Evolution of digestive physiology during vagal nerve stimulation | Digestive physiology is evaluated by intestinal transit time with Smartpill capsule, lactuose/mannitol intestinal permeability test, fecal calprotectin and blood cytokines | 3 and 6 months | 
| Effect of vagal nerve stimulation on quality of life | Quality of life and psychological questionnaires | 3 and 6 months | 
| Evaluation of sympatho-vagal balance | Measurement by nocturnal EKG Holter of the variability of the interval RR, as a marker of the sympatho-vagal balance | 0, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Vagal nerve stimulation, Quality of life