Cerebellar TMS and Satiety in Prader-Willi Syndrome

NCT05938543 | Recruiting FDA Device

• 1 other identifier: 2023P001354
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prader-Willi Syndrome

Outcome Measures

Primary Outcomes (3)

• Retention of subjects in study assessments

  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.

  1-week post-TMS follow-up visit

• Time required to enroll subjects into study

  Time required to enroll the target sample size (n=12) into the study

  At study completion, up to 18 months

• Change in BOLD response

  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)

  baseline, 1-week post-TMS follow-up visit

Study Arms (1)

Active cerebellum rTMS

EXPERIMENTAL

Cerebellar targeted iTBS, once daily, one week

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces an electrical current in neurons and allows for modulation of neural circuitry. Other Name: iTBS

Active cerebellum rTMS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Prader-Willi syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Foundation for Prader-Willi Research: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Prader-Willi Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Laura Holsen, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Holsen, PhD

CONTACT

617-525-8772; lholsen@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 10, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)