Personalized Transcranial Direct Current Stimulation in Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- fMRI functional connectivity biomarker
研究概览
简要总结
The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity.
详细描述
This is a randomized, sham controlled double masked parallel group study with optional crossover of chronic (>3mo from stroke onset) ischemic or hemorrhagic stroke patients to test the effect of ptDCS on a cerebral connectivity biomarker of plasticity during stimulation and after 10 treatment of up to 2 mA ptDCS. PtDCS will be performed during the first 20 minutes of occupational therapy targeting the weaker arm compared to sham. Patients will have the option to cross over after the completion of 1-month follow-up and will complete the same procedures with real tDCS if they were in the sham group.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4).
- •Age more than 18, Male or Female, All racial and ethnic groups
- •Entry into the study >3 months post onset
- •Modified Ashworth Scale Score <3 in the involved upper extremity
- •Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand
- •Able to follow 2 step commands
排除标准
- •Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions).
- •Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
- •Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age,epilepsy or others).
- •Patients with unstable cardiac arrhythmia.
- •Pregnancy
- •Patients with metallic implants in the head, patients with pacemakers, patients with craniotomies, including burr holes who cannot be safely stimulated
- •Patients with seizures
- •Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services.
研究组 & 干预措施
Sham tDCS
Same OT procedure and montage as with the active stimulation but the current will be increased then decreased ramp-like and switched off after 20 seconds instead of the 20 minutes to elicit the same cutaneous sensation as the other stimulation conditions.
干预措施: Sham tDCS with OT (Device)
Personalized Transcranial direct current stimulation (ptDCS)
TDCS is a noninvasive form of cortical stimulation that uses a battery-powered device. [67] Weak current (0.5-2 mA) will be delivered for up to 20 minutes through surface electrodes which will be positioned using the montage identified as the best in the individual stroke patient during our initial testing session during OT targeting the affected arm.
干预措施: Transcranial direct current stimulation (tDCS) with OT (Device)
结局指标
主要结局
fMRI functional connectivity biomarker
时间窗: baseline and 4 weeks
Task activation, resting state functional connectivity
次要结局
- Wolf Motor Function Test(4 weeks)
- Fugl-Meyer assessment(4 weeks)
研究者
Timea Hodics
Director, Interventional Neuro-Recovery Program
The Methodist Hospital Research Institute