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| Name | Class |
|---|---|
| John Bost Foundation | UNKNOWN |
| University Hospital, Bordeaux | OTHER |
| Hendaye hospital | UNKNOWN |
| Groupe Hospitalier Pitie-Salpetriere |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental |
| |
| Sham stimulation | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Every 2 weeks for 11 months (including 3 times before and post-stimulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Behavioral manifestations of executive functioning | BRIEF-A (Behavior Inventory Related to Executive Functions - Adult version) | 4 times (at 0, 3, 6 and 9 months) |
| Evaluation of Executive functions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virginie Postal, PhD | Contact | +33 (0)57 57 19 74 | virginie.postal@u-bordeaux.fr | |
| Camille Nahon, PhD student, neuropsychologist | Contact | +33 05 57 57 19 64 | camille.nahon@u-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Virginie Postal, PhD | University of Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reference Center of Prader-Willi Syndrome (PRADORT) | Not yet recruiting | Bordeaux | 33600 | France |
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| OTHER |
| University Hospital, Toulouse | OTHER |
| Prader-Willi Syndrome Association | OTHER |
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|
| 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. |
|
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.
| 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) | 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) | 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) | 4 times (at 0, 3, 6 and 9 months) |
| Reference Center of Prader-Willi Syndrome (CRMR PRADORT) | Recruiting | Hendaye | 64700 | France |
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| Reference Center of Prader-Willi Syndrome (PRADORT) | Recruiting | Paris | 75013 | France |
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| Reference Center of Prader-Willi Syndrome (PRADORT) | Recruiting | Toulouse | 31000 | France |
|
| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| D007266 | Inhibition, Psychological |
| D000080103 | Emotional Regulation |
| D001519 | Behavior |
| D006963 | Hyperphagia |
| D003863 | Depression |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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