Cerebellar TMS and Satiety in Prader-Willi Syndrome

Prader-Willi Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938543
• Other study ID #: 2023P001354
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: Brigham and Women's Hospital
• Contact: Laura Holsen, PhD
• Phone: 617-525-8772
• Email: lholsen[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

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