Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Tic severity
研究概览
简要总结
The aim of this study is to train patients with tic disorders to control activity in a region of their brain that has been associated with the urge to tic. Patients will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the region during these feedback sessions. In separate sessions, patients will be given sham feedback based on the brain patterns of a prior subject rather than their own brain patterns. Our primary hypothesis is that the biofeedback training will reduce their tic symptoms more than the sham feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Tourette Syndrome or Chronic Tic Disorder
- •currently active tics
- •aged 11-19
- •ability to execute most common tics without moving head while lying on back
排除标准
- •Blindness (because feedback is provided visually)
- •Lifetime diagnosis of pervasive developmental disorder, bipolar disorder, or psychotic disorder.
- •Presence of any serious psychiatric or psychosocial condition requiring initiation of new treatment or change in current treatment.
- •Neurological conditions affecting central nervous system, with the exception that predisposition to migraine will not be grounds for exclusion
- •Change in medication in the month prior to beginning the study
- •Unwillingness to keep medication stable over the course of the intervention
- •Full braces (but some retainers are OK)
- •Claustrophobia of a degree that they cannot comfortably be scanned
- •If common tics involve dramatic changes in breathing that could alter blood oxygenation measurements
- •Inability to keep head still while executing most common tics
- •Inability to keep head still in mock scanner
- •Inability or unwillingness to understand or follow the instructions
- •Pregnancy or possible pregnancy
- •Subjects may also be excluded after the first magnetic resonance scan if we are unable to localize a region of their supplementary motor area involved in tics - leaving us without a target area for biofeedback.
研究组 & 干预措施
Neurofeedback first
Neurofeedback then sham feedback
干预措施: Neurofeedback (Procedure)
Neurofeedback first
Neurofeedback then sham feedback
干预措施: Sham feedback (Procedure)
Sham first
Sham feedback then neurofeedback
干预措施: Sham feedback (Procedure)
Sham first
Sham feedback then neurofeedback
干预措施: Neurofeedback (Procedure)
结局指标
主要结局
Tic severity
时间窗: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.
A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity.
次要结局
- Control over target brain area(Assessed approximately half a week AFTER biofeedback/sham biofeedback.)