Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis Systemic Sclerosis (AVADIS)
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Details and patient eligibility
About
The purpose of this study is to assess the effect of transcutaneous auricular vagus nerve stimulation (ta-VNS) on gastrointestinal symptoms and quality of life in systemic sclerosis (SSc) patients.
Full description
Conduct of study:
Entry into the study: After informed consent, patients will be randomised into two arms (active or sham stimulation). The person responsible for setting the stimulator will make the randomization via an interactive web response system (IWRS). Only this person will have the knowledge of the group allocated to the patient.
Start of ta-VNS sessions according to the 1st modality of stimulation : The patient will perform 2 stimulation sessions per day at home for 3 months. During this period a clinical research associate will contact the patient to verify that he does not encounter any problems with the stimulator. An evaluation visit will be carried out at the end of these three months by a blind physician.
Wash-out period during 1 month.
Start of ta-VNS sessions according to the 2nd modality of stimulation : The patient will perform 2 stimulation sessions per day at home for 3 months. An evaluation visit will be conducted prior to the start of the sessions and another at the end of the sessions.
Enrollment
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Volunteers
Inclusion criteria
- SSc meeting ACR-EULAR (American College of Rheumatology- European League Against Rheumatism) criteria.
- Treatment by proton pump inhibitor (PPI) initiated for at least 3 months.
- Patient's written consent
- Affiliated with social security system
Exclusion criteria
- Patients who have previously received central or peripheral neurostimulation treatment regardless of indication.
- People equipped with an active pacemaker in the area of application of the stimulation electrodes.
- People with dermatological disease in the area of application of stimulation electrodes
- People with recent venous or arterial thrombosis (less than one month)
- People with a cochlear implant near the stimulation site
- People followed for proven heart disease
- Person who are protected under the act
- Pregnant or breastfeeding woman
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Sophie blaise, MD/PHD
Data sourced from clinicaltrials.gov
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