Prader-Willi Syndrome
Conditions
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.
Interventions
DEVICERepetitive 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
Sponsors
Foundation for Prader-Willi Research
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
Primary ContactLaura Holsen, PhD
Outcome results
None listed