Cerebellar TMS and Satiety in Prader-Willi Syndrome

Brigham and Women's Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Prader-Willi Syndrome

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

McLean Hospital

Belmont, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1-week post-TMS follow-up visit

Time required to enroll subjects into study

Time required to enroll the target sample size (n=12) into the study

Time frame: At study completion, up to 18 months

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)

Time frame: baseline, 1-week post-TMS follow-up visit

Central Contacts

Laura Holsen, PhD

CONTACT

617-525-8772 lholsen@bwh.harvard.edu

Data from ClinicalTrials.gov

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