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NCT Number: NCT06720571

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

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.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Behavior Behavioral Symptoms Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Depression Emotional Regulation Genetic Diseases, Inborn Hyperphagia Imprinting Disorders Inhibition, Psychological Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Signs and Symptoms, Digestive Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reference Center of Prader-Willi Syndrome (PRADORT), Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Evaluation of Behavioral manifestations of executive functioning

    Time frame: 4 times (at 0, 3, 6 and 9 months)

    BRIEF-A (Behavior Inventory Related to Executive Functions - Adult version)

  2. Evaluation of Executive functions

    Time frame: 4 times (at 0, 3, 6 and 9 months)

    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.

  3. Evaluation of Hyperphagia

    Time frame: 4 times (at 0, 3, 6 and 9 months)

    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)

  4. Evaluation of Depression

    Time frame: 4 times (at 0, 3, 6 and 9 months)

    Depression will be assessed using the Depression Self-Report Questionnaire (Beck Depression Inventory - BDI-II)

  5. Evaluation of Quality of life

    Time frame: 4 times (at 0, 3, 6 and 9 months)

    We will assess the quality of life of participants with PWS using the WHOQOL-BREF questionnaire (World Health Organization Quality of Life-BREF)

Study contacts

Contact information is provided by the study sponsor or research team.

Camille Nahon, PhD student, neuropsychologist

CONTACT

[email protected]

+33 05 57 57 19 64

Virginie Postal, PhD

CONTACT

[email protected]

+33 (0)57 57 19 74

Sponsors and collaborators

Lead sponsor

University of Bordeaux

Other

Collaborators

  • Groupe Hospitalier Pitie-Salpetriere
  • Hendaye hospital
  • John Bost Foundation
  • Prader-Willi Syndrome Association
  • University Hospital, Bordeaux
  • University Hospital, Toulouse

Registry information

Official study 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

Acronym: STIM-PRADER

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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