Systemic SclerosisAVADISNCT04971018
Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis Systemic Sclerosis
A study testing Auricular vagus nerve stimulation in people with Systemic Sclerosis, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- Auricular vagus nerve stimulation, Sham Auricular vagus nerve stimulation
- Keywords
- Transcutaneous auricular vagus nerve stimulation, Digestive symptoms, ta-VNS
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular vagus nerve stimulationDevice
Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
Sham Auricular vagus nerve stimulationDevice
Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Active ta-VNS | Experimental | Not described Receives: Device: Auricular vagus nerve stimulation |
| Sham ta-VNS | Placebo comparator | Not described Receives: Device: Sham Auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Comparison between the 2 groups of the evolution of the Health Assessment Questionnaire for scleroderma (sHAQ)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 0 to Month 3 for the first step. And from the month 4 to month 7 for the second step
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start9 Nov 2021
- Primary completion15 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971018
- Sponsor's protocol ID
- 38RC20.363
- Acronym
- AVADIS
- Status last verified
- Dec 2024
- First submitted
- 2 Jul 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04971018
- Acronym / sponsor ID
- AVADIS / 38RC20.363
- Conditions
- Systemic Sclerosis
- Keywords
- Transcutaneous auricular vagus nerve stimulation, Digestive symptoms, ta-VNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active ta-VNS | Experimental | Device: Auricular vagus nerve stimulation |
| Sham ta-VNS | Placebo comparator | Device: Sham Auricular vagus nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular vagus nerve stimulationPatients will have 20-minutes stimulation sessions at home twice a day during 3 months. | Device | Active ta-VNS |
| Sham Auricular vagus nerve stimulationPatients will have 20-minutes stimulation sessions at home twice a day during 3 months. | Device | Sham ta-VNS |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular vagus nerve stimulation in people with Systemic Sclerosis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.