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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion, up to 18 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with Prader-Willi syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion, up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in BOLD response
Retention of subjects in study assessments
Time required to enroll subjects into study
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
1,616 Previous Clinical Trials
11,470,928 Total Patients Enrolled
Foundation for Prader-Willi ResearchOTHER
13 Previous Clinical Trials
1,168 Total Patients Enrolled
12 Trials studying Prader-Willi Syndrome
988 Patients Enrolled for Prader-Willi Syndrome
Laura Holsen, PhDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a head injury that made you lose consciousness.You have a medical device implanted in your body, like a pacemaker or nerve stimulator.I have a history of seizures, epilepsy, or a close family member with epilepsy.You feel very uncomfortable in small, enclosed spaces like an MRI machine.I do not have a history of neurological disorders or conditions that prevent MRI or TMS.I have been diagnosed with Prader-Willi syndrome.You have metal in your brain or skull.
Research Study Groups:
This trial has the following groups:- Group 1: Active cerebellum rTMS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the requirements for participation in this research trial?
"Qualified candidates for this research initiative must have a diagnosis of Prader-Willi Syndrome and be between 18 to 64 years old. This particular trial is recruiting up to 20 volunteers in total."
Answered by AI
Are geriatric individuals being included in this clinical investigation?
"This research study is only open to individuals aged 18-64. There are 377 trials accepting patients below the eligible age range and 1000 for those over 65 years old."
Answered by AI
Are there still openings in this research study?
"The latest updates on clinicaltrials.gov suggest that this particular medical trial is not enrolling patients anymore as it was last updated in July of 2023. Nevertheless, there are 1428 different studies currently looking to add participants with various conditions and needs."
Answered by AI
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