Cerebellar TMS and Satiety in Prader-Willi Syndrome

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05938543

Collaborator

Foundation for Prader-Willi Research (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prader-Willi Syndrome	Device: Repetitive Transcranial Magnetic Stimulation (rTMS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active cerebellum rTMS Cerebellar targeted iTBS, once daily, one week	Device: 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

Arm

Intervention/Treatment

Experimental: Active cerebellum rTMS

Cerebellar targeted iTBS, once daily, one week

Device: 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

Outcome Measures

Primary Outcome Measures

Retention of subjects in study assessments [1-week post-TMS follow-up visit]
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.
Time required to enroll subjects into study [At study completion, up to 18 months]
Time required to enroll the target sample size (n=12) into the study
Change in BOLD response [baseline, 1-week post-TMS follow-up visit]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McLean Hospital	Belmont	Massachusetts	United States	02478

Sponsors and Collaborators

Brigham and Women's Hospital
Foundation for Prader-Willi Research

Investigators

Principal Investigator: Laura Holsen, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laura M Holsen, Associate Professor of Psychiatry, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT05938543

Other Study ID Numbers:

2023P001354

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Prader-Willi Syndrome

Syndrome

Study Results

No Results Posted as of Jul 10, 2023