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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Device: Auricular vagus nerve stimulation; Device: Sham Auricular vagus nerve stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie blaise, MD/PHD; Phone Number: +330476767575; Email: sblaise@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • vascular medicine department, University hospital
    • Contact: Sophie Blaise, MD/phd; Phone Number: 0476767575

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active ta-VNS	Device: Auricular vagus nerve stimulation; Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
Placebo Comparator: Sham ta-VNS	Device: Sham Auricular vagus nerve stimulation; Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Transcutaneous auricular vagus nerve stimulation; Digestive symptoms; ta-VNS
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 38RC20.363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No