Recruiting

Cerebellar TMS

Sponsor:

Brigham and Women's Hospital

Code:

NCT05938543

Conditions

Prader-Willi Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Details

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

Study ID

NCT05938543

Start date

Sep 1, 2023

Status verified date

Dec, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Active cerebellum rTMS

Cerebellar targeted iTBS, once daily, one week

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

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

Primary outcome measure

  • Retention of subjects in study assessments [ Time Frame: 1-week post-TMS follow-up visit ]
  • Time required to enroll subjects into study [ Time Frame: At study completion, up to 18 months ]
  • Change in BOLD response [ Time Frame: baseline, 1-week post-TMS follow-up visit ]

Central Contacts and Locations

Central contacts

Laura Holsen, PhD

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

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Mark Halko, PhD

mhalko@mclean.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-12-05.