NCT04971018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 9, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

July 2, 2021

Last Update Submit

December 3, 2024

Conditions

Systemic Sclerosis

Keywords

Transcutaneous auricular vagus nerve stimulationDigestive symptomsta-VNS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Effect of ta-VNS on quality of life.

    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

    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

    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

    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

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

  • +2 more secondary outcomes

Study Arms (2)

Active ta-VNS

EXPERIMENTAL
Device: Auricular vagus nerve stimulation

Sham ta-VNS

PLACEBO COMPARATOR
Device: Sham Auricular vagus nerve stimulation

Interventions

Auricular vagus nerve stimulationDEVICE

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

Active ta-VNS
Sham Auricular vagus nerve stimulationDEVICE

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

Sham ta-VNS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

vascular medicine department, University hospital

Grenoble, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 21, 2021

Study Start

November 9, 2021

Primary Completion

May 15, 2024

Study Completion

June 1, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)