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Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis Systemic Sclerosis

NCT ID: NCT04971018

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-09

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Systemic Sclerosis

Keywords

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Transcutaneous auricular vagus nerve stimulation Digestive symptoms ta-VNS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active ta-VNS

Group Type EXPERIMENTAL

Auricular vagus nerve stimulation

Intervention Type DEVICE

Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.

Sham ta-VNS

Group Type PLACEBO_COMPARATOR

Sham Auricular vagus nerve stimulation

Intervention Type DEVICE

Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.

Interventions

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Auricular vagus nerve stimulation

Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.

Intervention Type DEVICE

Sham Auricular vagus nerve stimulation

Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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vascular medicine department, University hospital

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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38RC20.363

Identifier Type: -

Identifier Source: org_study_id