Use of Anodal Transcranial Direct Current Stimulation to Enhance Upper Limb Recovery in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Upper Limb
研究概览
简要总结
This will be a randomized, blinded, sham-controlled trial. The medical device used, Soterix Medical 1x1 tDCS stimulator, is capable of delivering either real or sham tDCS and has been used in many randomised controlled trials in stroke patients.
50 patients with subacute stroke and severe upper limb weakness within 8 weeks of stroke on transfer to TTSH stroke rehab wards will be recruited over a period of 10 months. Recruited patients will be randomized into the intervention and control arms in a 1:1 ratio.
详细描述
The primary objective is to determine the clinical efficacy, technical feasibility and safety of anodal tDCS therapy to the unaffected hemisphere in hospitalized subacute stroke patients with severe arm weakness.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ever unilateral ischaemic or haemorrhagic stroke, as documented by CT or MRI scans
- •Age 21-80 years, both males and females
- •Within 8 weeks of stroke onset
- •Severe weakness of one upper limb, defined by a Shoulder Abduction and Finger Extension (SAFE) score < 5 (Medical Research Council grading)
- •Provision of informed consent by patient or a legal guardian in accordance with the local ethics committee guidelines and the Declaration of Helsinki
排除标准
- •Bilateral hemispheric or cerebellar strokes
- •Pre-existing arm pathology (e.g. contracture, severe pain, etc.) on the affected side
- •Presence of brain implants, and previous insertion of external ventricular drains.
- •Metallic implants at the level of the neck, mouth cavity and below are permitted (e.g. Cardiac stents, dental implants, pacemakers and other metallic objects)
- •A history of spontaneous seizures, epilepsy, brain tumour, and cranial surgery
- •Severe cognitive impairment (MOCA Score <10) that would hinder sufficient understanding of the instructions
- •Pregnancy
结局指标
主要结局
Fugl-Meyer Upper Limb
时间窗: At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)
Fugl-Meyer Upper Limb
次要结局
- Streamlined Wolf Motor Function Test (sWMFT)(At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3))
- Functional Independence Measure (FIM)(At baseline (Day 0) At end of 10 tDCS sessions (Day 10))
- EQ5D-5L(At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3))
- Rate of Adverse Events from tDCS(Immediately after each tDCS session (total 10 sessions of tDCS))