Transcranial Electrical Stimulation (tES) for the Treatment of Cervical Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score
研究概览
简要总结
There are two phases.
Phase I: A single visit which includes a screening, clinical scales, and a MRI scan with simultaneous tES/sham tES in a randomized block design. Enrolls both Cervical Dystonia (CD) patients and healthy controls.
Phase II: 5 consecutive days of 30-90 min visits to campus for tES or sham tES. Transcranial magnetic stimulation (TMS) measures and clinical scales will also be included on Day 1 and Day 5 visits. Enrolls only CD patients.
详细描述
Phase I:
Enrolls both CD patients and healthy controls.
One approximately 3 hour visit which includes:
- a screening & neurological exam,
- clinical scales & questionnaires,
- a (approx.) 60 min MRI scan with simultaneous tES/sham tES in a randomized block design and EMG
Phase II:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed
- •On a stable dose of all medications used to treat dystonia for the month previous to enrollment
- •No botox injections in the 10 weeks previous to enrollment
排除标准
- •Any contraindication to MRI scanning, tES, or TMS (e.g pregnancy, history of seizures, significant systemic medical conditions, untreated psychiatric or neurological conditions)
- •Evidence on neurological exam of any potentially confounding neurological disorder
- •Evidence of significant cognitive impairment
- •Patients with dystonia symptoms beginning prior to the age of 18 will be excluded
- •Patients with secondary dystonia resulting from medications or that are part of another neurological disorder (e.g. Parkinson's disease) will be excluded
- •Medication that might predispose the subject to seizures
- •Healthy Controls
- •Inclusion Criteria:
- •Right-handed
- •Exclusion Criteria:
- •Any contraindication to MRI scanning, tES, or TMS (e.g pregnancy, history of seizures, significant systemic medical conditions, untreated psychiatric or neurological conditions)
- •Evidence on neurological exam of any potentially confounding neurological disorder
- •Evidence of significant cognitive impairment
- •Medication that might predispose the subject to seizures
结局指标
主要结局
Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score
时间窗: Day 1, Day 5
A change in TWSTRS scores following five daily sessions of inhibitory tACS.
Phase I: A change in brain functional connectivity in primary cervical dystonia
时间窗: Day 1
A change in mean functional connectivity between the pallidum and putamen during a resting state in CD patients during inhibitory tACS targeting the sensorimotor network.
次要结局
未报告次要终点