Prader-Willi SyndromeSTIM-PRADERNCT06720571
Effects of Transcutaneous Vagus Nerve Stimulation on Emotion Regulation and Executive Functioning in Prader-Willi Syndrome
A study testing Auricular vagal neuromodulation therapy (aVNT) in people with Prader-Willi Syndrome, run by University of Bordeaux at 4 sites in France.
Trial summary
The STIM-PRADER study aims to assess the effectiveness of auricular vagal neuromodulation therapy (aVNT) on emotional, behavioral, and cognitive domains impaired in Prader-Willi Syndrome (PWS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Auricular vagal neuromodulation therapy (aVNT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesFrance
- Study dates
- 22 Nov 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participant with PWS: Age : ≥ 18 years old; Diagnosis of Prader-Willi syndrome with identified genotype; Intellectual Quotient ≥ 55 measured by WAIS-IV (abbreviated version); Pathological or threshold score on at least one of the BRIEF-A subscales; Adults volunteering and able to comply with study procedures; Signature of informed consent form; Beneficiary of a social security regime
- Caregivers: Caregivers involved in the participant's family, medical or institutional environment; Caregiver who has signed the informed consent form.
Who cannot join
- Participant with PWS: Untreated and unstabilized psychiatric and/or behavioral disorders (psychological decompensation within the last year); Severe visual or hearing impairment; Untreated sleep apnea syndrome; Epileptic seizures; Previous significative ECG abnormality; Adults with pacemakers or defibrillators; Metal or electronic devices implanted in the head; Participation in other research involving an exclusion period still in progress at inclusion; Score ≥ 30 indicating severe depression (BDI-II self-report questionnaire); Pregnant or breast-feeding women.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Reference Center of Prader-Willi Syndrome (PRADORT)
Bordeaux, 33600
Blandine Gatta Cherifi, MD, PhD, +33 05 57 62 32 07, blandine.gatta-cherifi@chu-bordeaux.fr
Blandine Gatta Cherifi, MD, PhD
- Recruiting
Reference Center of Prader-Willi Syndrome (CRMR PRADORT)
Hendaye, 64700
Fabien Mourre, MD, PhD, + 33 05 59 48 08 00, fabien.mourre@aphp.fr
Fabien Mourre, MD, PhD
- Recruiting
Reference Center of Prader-Willi Syndrome (PRADORT)
Paris, 75013
Christine Poitou-Bernert, MD, PhD, +33 01 42 17 57 71, christine.poitou-bernert@aphp.fr
Christine Poitou-Bernert, MD, PhD
- Recruiting
Reference Center of Prader-Willi Syndrome (PRADORT)
Toulouse, 31000
Emilie Montastier, MD, PhD, +33 (0)05 61 32 30 57, montastier.e@chu-toulouse.fr
Camille Nahon, PhD student, neuropsychologist, +33 05 57 57 19 64, camille.nahon@u-bordeaux.fr
About this study
Official title: Auricular Vagal Neuromodulation Therapy (aVNT) for Enhancing Emotion Regulation, Executive Functions, Hyperphagia, and Quality of Life in Prader-Willi Syndrome: A Multicenter Randomized Controlled Trial
The STIM-PRADER study aims to assess the effectiveness of auricular vagal neuromodulation therapy (aVNT) on emotional, behavioral, and cognitive domains impaired in Prader-Willi Syndrome (PWS). Currently, no treatment exists that addresses the multiple alterations associated with this rare neurodevelopmental disorder that significantly impact patients and their families. We will investigate the effects of daily, four-hour aVNT stimulation over a nine-month period on (a) emotion regulation, including assessing the persistence of effects following stimulation; (b) executive functions, including inhibition, flexibility, planning, and updating information in memory; (c) hyperphagia; (d) depression; (e) quality of life; (e) and the threshold at which effects on these dimensions can be observed.
We will conduct a longitudinal multicenter parallel randomized controlled single-blind exploratory trial. Twenty-four adults with PWS and 24 caregivers will be randomly assigned to receive either active or sham stimulation under identical conditions (four hours per day, seven days per week over nine months). The primary outcome, focusing on emotional control, will be assessed every two weeks for both participants and caregivers. Secondary outcomes (executive functions, hyperphagia, depression, and quality of life) will be measured at four time points: pre-intervention, at three months, six months, and at nine months.
As this is the first multicenter randomized controlled trial investigating the effects of aVNT as a treatment in PWS patients, we anticipate witnessing improved emotional regulation and reduced eating disorders, along with enhancements in executive functions and quality of life in the active stimulation group. The findings from this project could support the development of broader therapeutic approaches for other conditions in which behavioral disorders and emotional processing deficits affect patients and their caregivers.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Auricular vagal neuromodulation therapy (aVNT), Sham Auricular vagal neuromodulation therapy (aVNT)
- Keywords
- Prader-Willi Syndrome, Vagus nerve stimulation, aVNT, t-VNS, Cognition, Executive functions, Inhibition, Flexibility, Planning, Updating, Emotion regulation, Behavior, Hyperphagia, Quality of life, Depression, Multicenter randomized controlled trial, Caregivers
- Medical subject headings
- Prader-Willi Syndrome, Inhibition, Psychological, Emotional Regulation, Behavior, Hyperphagia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular vagal neuromodulation therapy (aVNT)Device
The aVNT device used in our study (Parasym ®) consists of a small portable unit connected to stimulation electrodes placed on the left ear. These electrodes deliver painless electrical microcurrents through the skin to stimulate the auricular branch of the vagus nerve (ABVN). The device parameters will be defined in accordance with the recommendations for use of the Parasym ® device and the pilot studies: frequency of 25 Hz, pulse width of 250 µS, and an intensity of 1 mA to 36 mA. Stimulation sessions will last for four hours each day, each of which can be divided into two sessions and conducted over a period of nine months. Patients will adjust the intensity at each session according to their comfort level, starting with a gradual increase until they feel a slight tingling sensation, followed by a decrease until discomfort disappears completely. Stimulation should take place during a relaxing activity but not should not take place during sleep, meals or major physical activity.
Sham Auricular vagal neuromodulation therapy (aVNT)Device
The sham stimulation control condition will be performed using the same aVNT Parasym® device under similar conditions (four hours a day, seven days a week, for nine months) but with a different location (without afferent vagus nerve fibers) or a control condition integrated into the device.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Not described Receives: Device: Auricular vagal neuromodulation therapy (aVNT) |
| Sham stimulation | Sham comparator | Not described Receives: Device: Sham Auricular vagal neuromodulation therapy (aVNT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of emotional control and regulation
The primary outcome measure will focus on assessing emotional control (EC) through a subscale of the BRIEF-A (Behavior Inventory Related to Executive Functions - Adult version).
Measured: Every 2 weeks for 11 months (including 3 times before and post-stimulation)
Secondary outcomes (5)
Evaluation of Behavioral manifestations of executive functioning
BRIEF-A (Behavior Inventory Related to Executive Functions - Adult version)
Measured: 4 times (at 0, 3, 6 and 9 months)
Evaluation of Executive functions
Behavioral inhibition will be assessed using a computerized Go/NoGo task and cognitive flexibility with a computerized voluntary alternation task. Planning abilities will be assessed using the BADS Zoo Test (Behavioral Assessment of Dysexecutive Syndrome - BADS). Finally, the ability to update information will be assessed using an adapted computerized N-2-Back task.
Measured: 4 times (at 0, 3, 6 and 9 months)
Evaluation of Hyperphagia
Hyperphagia will be assessed using a scale derived from the Dykens Hyperphagia Questionnaire: the HQ-CT (Hyperphagia Questionnaire for Use in Prader-Willi Syndrome Clinical Trials)
Measured: 4 times (at 0, 3, 6 and 9 months)
Evaluation of Depression
Depression will be assessed using the Depression Self-Report Questionnaire (Beck Depression Inventory - BDI-II)
Measured: 4 times (at 0, 3, 6 and 9 months)
Evaluation of Quality of life
We will assess the quality of life of participants with PWS using the WHOQOL-BREF questionnaire (World Health Organization Quality of Life-BREF)
Measured: 4 times (at 0, 3, 6 and 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start22 Nov 2023
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- John Bost Foundation, University Hospital, Bordeaux, Hendaye hospital, Groupe Hospitalier Pitie-Salpetriere, University Hospital, Toulouse, Prader-Willi Syndrome Association
- Responsible party
- Principal investigator, Virginie Postal, University of Bordeaux
- Investigators
- Virginie Postal, PhD, Principal investigator, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720571
- Sponsor's protocol ID
- 2023-A00915-40
- Acronym
- STIM-PRADER
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Auricular Vagal Neuromodulation Therapy (aVNT) for Enhancing Emotion Regulation, Executive Functions, Hyperphagia, and Quality of Life in Prader-Willi Syndrome: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06720571
- Acronym / sponsor ID
- STIM-PRADER / 2023-A00915-40
- Conditions
- Prader-Willi Syndrome
- Keywords
- Prader-Willi Syndrome, Vagus nerve stimulation, aVNT, t-VNS, Cognition, Executive functions, Inhibition, Flexibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Collaborators
- John Bost Foundation, University Hospital, Bordeaux, Hendaye hospital, Groupe Hospitalier Pitie-Salpetriere, University Hospital, Toulouse, Prader-Willi Syndrome Association
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 6 Dec 2024 (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 STIM-PRADER study aims to assess the effectiveness of auricular vagal neuromodulation therapy (aVNT) on emotional, behavioral, and cognitive domains impaired in Prader-Willi Syndrome (PWS). Currently, no treatment exists that addresses the multiple alterations associated with this rare neurodevelopmental disorder that significantly impact patients and their families. We will investigate the effects of daily, four-hour aVNT stimulation over a nine-month period on (a) emotion regulation, including assessing the persistence of effects following stimulation; (b) executive functions, including inhibition, flexibility, planning, and updating information in memory; (c) hyperphagia; (d) depression; (e) quality of life; (e) and the threshold at which effects on these dimensions can be observed.
We will conduct a longitudinal multicenter parallel randomized controlled single-blind exploratory trial. Twenty-four adults with PWS and 24 caregivers will be randomly assigned to receive either active or sham stimulation under identical conditions (four hours per day, seven days per week over nine months). The primary outcome, focusing on emotional control, will be assessed every two weeks for both participants and caregivers. Secondary outcomes (executive functions, hyperphagia, depression, and quality of life) will be measured at four time points: pre-intervention, at three months, six months, and at nine months.
As this is the first multicenter randomized controlled trial investigating the effects of aVNT as a treatment in PWS patients, we anticipate witnessing improved emotional regulation and reduced eating disorders, along with enhancements in executive functions and quality of life in the active stimulation group. The findings from this project could support the development of broader therapeutic approaches for other conditions in which behavioral disorders and emotional processing deficits affect patients and their caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: Auricular vagal neuromodulation therapy (aVNT) |
| Sham stimulation | Sham comparator | Device: Sham Auricular vagal neuromodulation therapy (aVNT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant with PWS: Age : ≥ 18 years old; Diagnosis of Prader-Willi syndrome with identified genotype; Intellectual Quotient ≥ 55 measured by WAIS-IV (abbreviated version); Pathological or threshold score on at least one of the BRIEF-A subscales; Adults volunteering and able to comply with study procedures; Signature of informed consent form; Beneficiary of a social security regime
- Caregivers: Caregivers involved in the participant's family, medical or institutional environment; Caregiver who has signed the informed consent form.
Key exclusion criteria (1 listed)
- Participant with PWS: Untreated and unstabilized psychiatric and/or behavioral disorders (psychological decompensation within the last year); Severe visual or hearing impairment; Untreated sleep apnea syndrome; Epileptic seizures; Previous significative ECG abnormality; Adults with pacemakers or defibrillators; Metal or electronic devices implanted in the head; Participation in other research involving an exclusion period still in progress at inclusion; Score ≥ 30 indicating severe depression (BDI-II self-report questionnaire); Pregnant or breast-feeding women.
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 vagal neuromodulation therapy (aVNT)The aVNT device used in our study (Parasym ®) consists of a small portable unit connected to stimulation electrodes placed on the left ear. These electrodes deliver painless electrical microcurrents through the skin to stimulate the auricular branch of the vagus nerve (ABVN). The device parameters will be defined in accordance with the recommendations for use of the Parasym ® device and the pilot studies: frequency of 25 Hz, pulse width of 250 µS, and an intensity of 1 mA to 36 mA. Stimulation sessions will last for four hours each day, each of which can be divided into two sessions and conducted over a period of nine months. Patients will adjust the intensity at each session according to their comfort level, starting with a gradual increase until they feel a slight tingling sensation, followed by a decrease until discomfort disappears completely. Stimulation should take place during a relaxing activity but not should not take place during sleep, meals or major physical activity. | Device | Active stimulation |
| Sham Auricular vagal neuromodulation therapy (aVNT)The sham stimulation control condition will be performed using the same aVNT Parasym® device under similar conditions (four hours a day, seven days a week, for nine months) but with a different location (without afferent vagus nerve fibers) or a control condition integrated into the device. | Device | Sham stimulation |
Primary outcome
Evaluation of emotional control and regulation
Time frame: Every 2 weeks for 11 months (including 3 times before and post-stimulation)
The primary outcome measure will focus on assessing emotional control (EC) through a subscale of the BRIEF-A (Behavior Inventory Related to Executive Functions - Adult version).
5 secondary outcomes
Evaluation of Behavioral manifestations of executive functioning
Time frame: 4 times (at 0, 3, 6 and 9 months)
Evaluation of Executive functions
Time frame: 4 times (at 0, 3, 6 and 9 months)
Evaluation of Hyperphagia
Time frame: 4 times (at 0, 3, 6 and 9 months)
Evaluation of Depression
Time frame: 4 times (at 0, 3, 6 and 9 months)
Evaluation of Quality of life
Time frame: 4 times (at 0, 3, 6 and 9 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Virginie Postal, PhD principal investigator
University of Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular vagal neuromodulation therapy (aVNT) in people with Prader-Willi Syndrome, run by University of Bordeaux at 4 sites 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 2 inclusion and 1 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: looking for participants now, 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 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginie Postal, PhD (+33 (0)57 57 19 74, virginie.postal@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of emotional control and regulation (time frame: Every 2 weeks for 11 months (including 3 times before and post-stimulation)). 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.