ClinicalTrials.gov record NCT05938543

Cerebellar TMS and Satiety in Prader-Willi Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Noninvasive Neuromodulation of a Novel Cerebellar Satiety Circuit in Prader-Willi Syndrome

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old to 64 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study uses repetitive transcranial magnetic stimulation (rTMS) targeted to the cerebellum to study brain activation and satiety in people with Prader-Willi Syndrome aged 18–64. Participants receive daily intermittent theta-burst rTMS for one week and have assessments at baseline and one week after stimulation. The primary purpose is basic science: to measure brain-response changes and feasibility (retention and enrollment time). The study does not state that personal medical benefit will occur.

What it is studying. The study is testing whether cerebellar rTMS changes functional brain activation (measured by BOLD response) in regions including the cerebellum and ventral striatum, and how these changes relate to satiety and hyperphagia measures. It also measures feasibility outcomes: retention of participants through the follow-up visit and the time needed to enroll the planned 12 participants.

What the researchers hope to learn. Scientific goals: to learn whether cerebellar TMS alters brain activation in the cerebellum and ventral striatum, to explore links between those changes and satiety/hyperphagia in Prader-Willi Syndrome, and to assess feasibility measures (participant retention and time to enroll).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have baseline assessments including brain imaging, receive cerebellar-targeted repetitive transcranial magnetic stimulation (rTMS; also called iTBS) once daily for one week, and return about one week after the final session for repeat assessments and brain imaging to measure changes in brain activity (BOLD response). rTMS is noninvasive and delivered with a coil held against the scalp. The registry record does not list other procedures, tests, or participant support services.

How the study is structured. Interventional, single-group study with no masking. All participants receive active cerebellar intermittent theta-burst rTMS (iTBS) once daily for one week. Assessments occur at baseline and at a 1-week post-rTMS follow-up and include brain imaging to measure functional activation.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Prader-Willi syndrome

Clinical trials19 trials listed for Prader-Willi syndromeEvery trial the registry lists for Prader-Willi syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Prader-Willi syndrome researchLatest monthly update: September 2026. Includes: Hunger symptoms. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 1, 2023
Primary completion
September 2026 (estimated)
Study completion
October 2026 (estimated)
Target enrollment
20 participants (estimated)
Last updated on registry
Dec 5, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Brigham and Women's Hospital
Principal investigator
Laura M Holsen, Associate Professor of Psychiatry
Brigham and Women's Hospital
Collaborators
  • Foundation for Prader-Willi Research

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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