Clinical trial NCT04971018: Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis Systemic Sclerosis
Official title: Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: Transcutaneous auricular vagus nerve stimulation
Digestive symptoms
ta-VNS
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of ta-VNS on Evolution of Gastrointestinal Quality of life.
timeFrame: 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
Secondary outcomes:
measure: Effect of ta-VNS on quality of life.
timeFrame: 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
measure: Effect of ta-VNS on flexibility of the autonomic nervous system
timeFrame: day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
measure: Effect of ta-VNS on anxiety and Depression
timeFrame: 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
measure: Effect of ta-VNS on gastric motility
timeFrame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
measure: Effect of ta-VNS on digestive symptomatic treatments used
timeFrame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
measure: Effect of ta-VNS on the number and location of digital ulcers.
timeFrame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
measure: Effect of ta-VNS on Raynaud's Condition Score (RCS)
timeFrame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Other outcomes:
Locations:
city: Grenoble
country: France
facility: vascular medicine department, University hospital
Study officials:
References: