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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active ta-VNS | Experimental |
| |
| Sham ta-VNS | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular vagus nerve stimulation | Device | Patients will have 20-minutes stimulation sessions at home twice a day during 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of ta-VNS on quality of life. | Comparison between the 2 groups of the evolution of the Health Assessment Questionnaire for scleroderma (sHAQ) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| vascular medicine department, University hospital | Grenoble | France |
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| Sham Auricular vagus nerve stimulation | Device | Patients will have 20-minutes stimulation sessions at home twice a day during 3 months. |
|
Comparison between the 2 groups of the evolution of heart rate variability (HRV) |
| 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). | 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. | 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 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. | 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. | 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). | Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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