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rTMS for Prader-Willi Syndrome

N/A
Recruiting
Led By Laura Holsen, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Prader-Willi syndrome
Be between 18 and 65 years old
Must not have
History of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy
Contraindications for TMS or MRI including history of neurological disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion, up to 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial uses non-invasive TMS to study how it can improve hyperphagia & satiety in Prader-Willi Syndrome.

Who is the study for?
This trial is for individuals with Prader-Willi syndrome. Participants must not have a history of neurological disorders, head trauma with unconsciousness, seizures or epilepsy (including in close relatives), metal in the brain or skull, implanted medical devices like pacemakers, or claustrophobia in MRI machines.
What is being tested?
The study is testing repetitive Transcranial Magnetic Stimulation (rTMS) on participants to see if it can help control excessive hunger and improve feelings of fullness in those with Prader-Willi syndrome. rTMS uses magnetic fields to stimulate brain activity noninvasively.
What are the potential side effects?
While rTMS is generally considered safe, potential side effects may include discomfort at the stimulation site, headache, lightheadedness, tingling sensations or muscle contractions. Serious side effects are rare but could involve seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Prader-Willi syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of seizures, epilepsy, or a close family member with epilepsy.
Select...
I do not have a history of neurological disorders or conditions that prevent MRI or TMS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion, up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in BOLD response
Retention of subjects in study assessments
Time required to enroll subjects into study

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active cerebellum rTMSExperimental Treatment1 Intervention
Cerebellar targeted iTBS, once daily, one week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,246 Total Patients Enrolled
Foundation for Prader-Willi ResearchOTHER
13 Previous Clinical Trials
1,154 Total Patients Enrolled
12 Trials studying Prader-Willi Syndrome
974 Patients Enrolled for Prader-Willi Syndrome
Laura Holsen, PhDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Active cerebellum rTMS Clinical Trial Eligibility Overview. Trial Name: NCT05938543 — N/A
Prader-Willi Syndrome Research Study Groups: Active cerebellum rTMS
Prader-Willi Syndrome Clinical Trial 2023: Active cerebellum rTMS Highlights & Side Effects. Trial Name: NCT05938543 — N/A
Active cerebellum rTMS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05938543 — N/A
~9 spots leftby Jan 2026
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