Noninvasive Neuromodulation of a Novel Cerebellar Satiety Circuit in Prader-Willi Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Retention of subjects in study assessments
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Prader-Willi syndrome
排除标准
- •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
结局指标
主要结局
Retention of subjects in study assessments
时间窗: 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
时间窗: At study completion, up to 18 months
Time required to enroll the target sample size (n=12) into the study
Change in BOLD response
时间窗: 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)
次要结局
未报告次要终点
研究者
Laura M Holsen
Associate Professor of Psychiatry
Brigham and Women's Hospital