Actively Recruiting
Noninvasive Neuromodulation of a Novel Cerebellar Satiety Circuit in Prader-Willi Syndrome
Led by Brigham and Women's Hospital · Updated on 2025-12-05
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
F
Foundation for Prader-Willi Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how a noninvasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) might affect hunger and feelings of fullness in people with Prader-Willi syndrome. This condition is associated with severe overeating, and the study aims to understand how stimulating a specific brain area, the cerebellum, may impact these symptoms. The study is sponsored by Brigham and Women's Hospital and involves adults aged 18 to 64 years. Participants will receive daily targeted rTMS treatments to the cerebellum for one week. This procedure uses a magnetic coil held by the scalp to create a magnetic field that temporarily changes brain activity. The rTMS method used, called intermittent theta burst stimulation (iTBS), is designed to modulate brain circuits linked to appetite control. During the study, participants will be monitored at baseline and then again one week after the rTMS treatment to measure brain responses using BOLD imaging and to assess retention in study assessments. Researchers will also track how long it takes to enroll subjects over the course of up to 18 months. The study does not involve masking or placebo and focuses on understanding brain function related to hyperphagia in Prader-Willi syndrome.
CONDITIONS
Brief Title
Cerebellar TMS and Satiety in Prader-Willi Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Prader-Willi syndrome
- Age between 18 and 64 years
You will not qualify if you...
- 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
- Presence of metal in brain or skull
- Implanted devices such as pacemaker, medication pump, nerve stimulator, or ventriculoperitoneal shunt
- Claustrophobia preventing MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive cerebellar targeted intermittent theta burst stimulation (iTBS) once daily for one week.
7 visits (in-person, daily)
Duration - 1 week post-implementation
Participants return for a follow-up visit one week after completing the neuromodulation sessions to assess retention and brain response changes.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
Research Team
L
Laura Holsen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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