Cerebellar TMS and Satiety in Prader-Willi Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive Transcranial Magnetic Stimulation (rTMS).
- Who it may be relevant to
- Registry conditions: Prader-Willi Syndrome. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Noninvasive Neuromodulation of a Novel Cerebellar Satiety Circuit in Prader-Willi Syndrome
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.
Interventions
- 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
Primary outcome measures
- Retention of subjects in study assessments [Time frame: 1-week post-TMS follow-up visit]
- Time required to enroll subjects into study [Time frame: At study completion, up to 18 months]
- Change in BOLD response [Time frame: baseline, 1-week post-TMS follow-up visit]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- McLean Hospital — Belmont
Identifiers
NCT: NCT05938543 · 2023P001354