Noninvasive Neuromodulation of a Novel Cerebellar Satiety Circuit in Prader-Willi Syndrome
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prader-Willi Syndrome
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Retention of subjects in study assessments
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Laura M Holsen
Associate Professor of Psychiatry
Brigham and Women's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Retention of subjects in study assessments
Time Frame: 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
Time Frame: At study completion, up to 18 months
Time required to enroll the target sample size (n=12) into the study
Change in BOLD response
Time Frame: 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)