Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT02420158
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2015-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StVSII
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: