Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits
研究概览
简要总结
The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.
详细描述
All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered by the American Academy of Neurology to be the first-line intervention for tics. Immediately prior to each CBIT session, participants will undergo TMS targeting the SMA. The specific type of TMS procedure will be randomly assigned between subjects and be either: 1 Hz repetitive TMS (rTMS), continuous theta burst stimulation (cTBS), or sham stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
- •At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
- •Full scale IQ greater than or equal to 70
- •English fluency to ensure comprehension of study measures and instructions.
- •Right-handed
排除标准
- •Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or participants of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician
- •Inability to undergo MRI.
- •Left handedness.
- •Active suicidality.
- •Previous diagnosis of psychosis or cognitive disability.
- •Substance abuse or dependence within the past year.
- •Concurrent psychotherapy focused on tics.
- •Neuroleptic/antipsychotic medications.
- •Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
结局指标
主要结局
Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits
时间窗: baseline to post-treatment; approximately 10 days
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
Change in SMA Activation
时间窗: baseline to post-treatment; approximately 10 days
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
次要结局
- Change in Tic Suppression Task(baseline to 3 months post-treatment)
- Safety: Measured as Rate of Adverse Events Related to Study Treatment(approximately 3-4 months)
- Feasibility: Measured as Participant Treatment Completion(approximately 3-4 months)