Skip to main content
OpenTrials
Completed

NCT Number: NCT04971018

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

vascular medicine department, University hospital

Grenoble, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular vagus nerve stimulation

Device

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

Sham Auricular vagus nerve stimulation

Device

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

Primary outcomes

  1. Effect of ta-VNS on Evolution of Gastrointestinal Quality of life.

    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

    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.

Secondary outcomes

  1. Effect of ta-VNS on quality of life.

    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

    Comparison between the 2 groups of the evolution of the Health Assessment Questionnaire for scleroderma (sHAQ)

  2. Effect of ta-VNS on flexibility of the autonomic nervous system

    Time frame: day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step

    Comparison between the 2 groups of the evolution of heart rate variability (HRV)

  3. Effect of ta-VNS on anxiety and Depression

    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

    Comparison between the 2 groups of the Hospital Anxiety and Depression Scale (HADS). HADS score ranges from 0 (better) to 42 (worse).

  4. Effect of ta-VNS on gastric motility

    Time frame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step

    Comparison between the 2 groups of the frequency of gastric waves assessed with a electrogastrography.

  5. Effect of ta-VNS on digestive symptomatic treatments used

    Time frame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step

    Comparison between the 2 groups :

    Description of the treatments taken by patients, the evolution of their posology, the frequency of administration.

  6. Effect of ta-VNS on 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

    Comparison between the 2 groups of the number and location of digital ulcers.

  7. Effect of ta-VNS on Raynaud's Condition Score (RCS)

    Time frame: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: AVADIS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.