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

Primary Purpose

Systemic Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auricular vagus nerve stimulation
Sham Auricular vagus nerve stimulation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring Transcutaneous auricular vagus nerve stimulation, Digestive symptoms, ta-VNS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • vascular medicine department, University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active ta-VNS

Sham ta-VNS

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect of ta-VNS on quality of life.
Comparison between the 2 groups of the evolution of the Health Assessment Questionnaire for scleroderma (sHAQ)
Effect of ta-VNS on flexibility of the autonomic nervous system
Comparison between the 2 groups of the evolution of heart rate variability (HRV)
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).
Effect of ta-VNS on gastric motility
Comparison between the 2 groups of the frequency of gastric waves assessed with a electrogastrography.
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.
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.
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).

Full Information

First Posted
July 2, 2021
Last Updated
May 16, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT04971018
Brief Title
Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis Systemic Sclerosis
Acronym
AVADIS
Official Title
Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
Transcutaneous auricular vagus nerve stimulation, Digestive symptoms, ta-VNS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active ta-VNS
Arm Type
Experimental
Arm Title
Sham ta-VNS
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Auricular vagus nerve stimulation
Intervention Description
Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
Intervention Type
Device
Intervention Name(s)
Sham Auricular vagus nerve stimulation
Intervention Description
Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
Primary Outcome Measure Information:
Title
Effect of ta-VNS on Evolution of Gastrointestinal Quality of life.
Description
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.
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
Secondary Outcome Measure Information:
Title
Effect of ta-VNS on quality of life.
Description
Comparison between the 2 groups of the evolution of the Health Assessment Questionnaire for scleroderma (sHAQ)
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
Title
Effect of ta-VNS on flexibility of the autonomic nervous system
Description
Comparison between the 2 groups of the evolution of heart rate variability (HRV)
Time Frame
day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Title
Effect of ta-VNS on anxiety and Depression
Description
Comparison between the 2 groups of the Hospital Anxiety and Depression Scale (HADS). HADS score ranges from 0 (better) to 42 (worse).
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
Title
Effect of ta-VNS on gastric motility
Description
Comparison between the 2 groups of the frequency of gastric waves assessed with a electrogastrography.
Time Frame
Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Title
Effect of ta-VNS on digestive symptomatic treatments used
Description
Comparison between the 2 groups : Description of the treatments taken by patients, the evolution of their posology, the frequency of administration.
Time Frame
Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Title
Effect of ta-VNS on the number and location of digital ulcers.
Description
Comparison between the 2 groups of 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
Title
Effect of ta-VNS on Raynaud's Condition Score (RCS)
Description
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).
Time Frame
Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie blaise, MD/PHD
Phone
+330476767575
Email
sblaise@chu-grenoble.fr
Facility Information:
Facility Name
vascular medicine department, University hospital
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Blaise, MD/phd
Phone
0476767575

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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