Cerebellar TMS and Satiety in Prader-Willi Syndrome
ConditionPrader-Willi Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Prader-Willi syndrome
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation (rTMS)
DevicerTMS 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Active cerebellum rTMSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 visit2
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 months3
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 visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Foundation for Prader-Willi Research
Collaborator
Source ClinicalTrials.gov