Safety and efficacy of adjunctive transcranial direct current stimulation (t DCS) in the management of post-stroke upper limb spasticity: a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To assess the efficacy of adjunctive tDCS in reducing post-stroke upper limb spasticity compared to sham tDCS alone by measuring the changes in the Modified Ashworth Scale (MAS) score over 4 weeks.
研究概览
简要总结
This study is a prospective, randomized controlled trial designed to evaluate the safety and efficacy of adjunctive transcranial direct current stimulation (tDCS) in adult patients with post-stroke upper limb spasticity. The trial will compare active tDCS combined with standard rehabilitation therapy to sham tDCS combined with standard therapy over a four-week period. The primary hypothesis is that tDCS will significantly reduce upper limb spasticity as measured by the Modified Ashworth Scale compared to sham stimulation. Secondary outcomes include improvements in motor function, functional performance, quality of life, and monitoring of safety outcomes. Participants will be followed at four weeks and three months post-intervention to evaluate both immediate and sustained effects. The study aims to provide evidence for tDCS as a safe and effective non-invasive adjunct therapy to enhance upper limb recovery in patients with chronic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •First ever ischemic or hemorrhagic stroke confirmed clinically and radiologically Stroke onset greater than or equal to 3 months to 2 years before enrolment MAS score greater than or equal to 2 in affected upper limb Stable medication and rehabilitation regimen with no major changes in spasticity drugs in past 4 weeks.
排除标准
- •History of epilepsy, CNS tumors, or neurodegenerative disorders Pacemaker or metallic implants Recurrent stroke Severe cognitive impairment or psychiatric disorders interfering with participation Pre-existing severe musculoskeletal conditions in affected limb Uncontrolled hypertension or hemodynamic instability Active skin lesions at electrode sites Pregnancy.
结局指标
主要结局
To assess the efficacy of adjunctive tDCS in reducing post-stroke upper limb spasticity compared to sham tDCS alone by measuring the changes in the Modified Ashworth Scale (MAS) score over 4 weeks.
时间窗: Baseline and 4 weeks post-intervention
次要结局
- To evaluate the safety and tolerability of tDCS in post stroke spasticity at 4 weeks(Baseline and 4 weeks post-intervention)
- To compare changes in motor function using the Fugl-Meyer Assessment upper extremity (FMA-UE) scale be-tween the 2 groups at 4 weeks(Baseline and 4 weeks post-intervention)
- To compare the quality of life improvements using the Stroke Impact Scale between the 2 groups at 4 weeks.(Baseline and 4 weeks post-intervention)
- To compare functional improvement between the 2 groups, including manual dexterity and daily activity performance, using the Jebsen-Taylor Hand Function Test at 4 weeks(Baseline and 4 weeks post-intervention)
- To analyse the sustained effects of tDCS on spasticity at follow-up (3 months post-intervention)(Baseline and 4 weeks post-intervention)
研究者
Ranjeet Kumar
Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research