Cerebellar TMS and Satiety in Prader-Willi Syndrome

Not Applicable

Recruiting

• Conditions: Prader-Willi Syndrome
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT05938543
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study hyperphagia and satiety in Prader-Willi syndrome.

TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study, the investigators will be stimulating the brain to learn more about how TMS might improve hyperphagia in Prader-Willi syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-10
• Study Start: 2023-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of Prader-Willi syndrome

Exclusion Criteria

• contraindications for TMS or MRI including :
• history of neurological disorder
• history of head trauma resulting in loss of consciousness
• history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy
• metal in brain or skull
• implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt claustrophobic in MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active cerebellum rTMS	Repetitive Transcranial Magnetic Stimulation (rTMS)	Cerebellar targeted iTBS, once daily, one week

Primary Outcome Measures

Name	Time	Method
Retention of subjects in study assessments	1-week post-TMS follow-up visit	Retention of subjects for assessments at baseline and 1-week post-TMS follow-up visit, as measured by the percentage (%) of enrolled subjects who complete baseline assessments and then go on to complete the 1-week post-TMS follow-up visit.
Time required to enroll subjects into study	At study completion, up to 18 months	Time required to enroll the target sample size (n=12) into the study
Change in BOLD response	baseline, 1-week post-TMS follow-up visit	Change in functional activation of the cerebellum and ventral striatum will be assessed before (baseline) and after TMS stimulation (1-week post-TMS follow-up visit)

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States