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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
vascular medicine department, University hospital
Grenoble, France
Effect of ta-VNS on Evolution of Gastrointestinal Quality of life.
Comparison between the 2 groups of the evolution of the total score University of California, Los Angeles - Scleroderma Clinical Trial Consortium - Gastrointestinal Tract Instrument, version 2.0 ( UCLA-SCTC-GIT 2.0). This score is specific to the SSc, assessing gastrointestinal symptoms and quality of life, validated in French.
Time frame: Evolution of UCLA-SCTC-GIT 2.0 will be assessed from day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Effect of ta-VNS on quality of life.
Comparison between the 2 groups of the evolution of the Health Assessment Questionnaire for scleroderma (sHAQ)
Time frame: Evolution of sHAQ will be assessed from day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Effect of ta-VNS on flexibility of the autonomic nervous system
Comparison between the 2 groups of the evolution of heart rate variability (HRV)
Time frame: day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Effect of ta-VNS on anxiety and Depression
Comparison between the 2 groups of the Hospital Anxiety and Depression Scale (HADS). HADS score ranges from 0 (better) to 42 (worse).
Time frame: HADS will be assessed from day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Effect of ta-VNS on gastric motility
Comparison between the 2 groups of the frequency of gastric waves assessed with a electrogastrography.
Time frame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
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Effect of ta-VNS on digestive symptomatic treatments used
Comparison between the 2 groups : Description of the treatments taken by patients, the evolution of their posology, the frequency of administration.
Time frame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Effect of ta-VNS on the number and location of digital ulcers.
Comparison between the 2 groups of the number and location of digital ulcers.
Time frame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Effect of ta-VNS on Raynaud's Condition Score (RCS)
Comparison between the 2 groups of the Raynaud's Condition Score (RCS). RCS is a 10 points scale ranging from 0 (better) to 10 (worse).
Time frame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step