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Effects of Transcutaneous Vagus Nerve Stimulation on Emotion Regulation and Executive Functioning in Prader-Willi Syndrome

NCT ID: NCT06720571

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prader-Willi Syndrome

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active stimulation

Group Type EXPERIMENTAL

Auricular vagal neuromodulation therapy (aVNT)

Intervention Type 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 stimulation

Group Type SHAM_COMPARATOR

Sham Auricular vagal neuromodulation therapy (aVNT)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John Bost Foundation

UNKNOWN

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

Hendaye hospital

UNKNOWN

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role collaborator

Prader-Willi Syndrome Association

OTHER

Sponsor Role collaborator

University of Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Virginie Postal

Researcher and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virginie Postal, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bordeaux

Locations

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Reference Center of Prader-Willi Syndrome (PRADORT)

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Reference Center of Prader-Willi Syndrome (CRMR PRADORT)

Hendaye, , France

Site Status RECRUITING

Reference Center of Prader-Willi Syndrome (PRADORT)

Paris, , France

Site Status RECRUITING

Reference Center of Prader-Willi Syndrome (PRADORT)

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Virginie Postal, PhD

Role: CONTACT

Phone: +33 (0)57 57 19 74

Email: [email protected]

Camille Nahon, PhD student, neuropsychologist

Role: CONTACT

Phone: +33 05 57 57 19 64

Email: [email protected]

Facility Contacts

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Blandine Gatta Cherifi, MD, PhD

Role: primary

Fabien Mourre, MD, PhD

Role: primary

Christine Poitou-Bernert, MD, PhD

Role: primary

Emilie Montastier, MD, PhD

Role: primary

Camille Nahon, PhD student, neuropsychologist

Role: backup

Other Identifiers

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2023-A00915-40

Identifier Type: -

Identifier Source: org_study_id