A randomized controlled trial to compare the efficacy of coupled transcranial stimulation with decoupled transcranial stimulation and sham stimulation as motor enhancement therapy for upper extremity in chronic ischemic stroke cases

JIPMER1 个研究点分布在 1 个国家目标入组 112 人开始时间: 2019年11月14日最近更新: 2021年7月6日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: JIPMER
入组人数: 112
试验地点: 1
主要终点: Fugl-Meyer Assessment - Upper extremity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In search of finding out a new paradigm to maximize the therapeutic effect, the study aims to couple the neurostimulatory repetitive transcranial magnetic stimulation after priming the brain using neuromodulatory transcranial direct current stimulation to enhance the upper extremity motor function in chronic ischemic post stroke cases.

研究设计

研究类型: Interventional
分配方式: Stratified block randomization
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•a)Age between 18year and 70year b)Cases diagnosed as stroke by MRI/CT scan as non-recurrent chronic MCA ischemic stroke c)Cases after six months of post stroke d)Normal as per Montreal Cognitive Assessment e)Brunnstrom 3-5 stages of recovery R.

排除标准

•a)Any contraindications for rTMS/tDCS intervention.
•b)Any other associated neuropsychiatric disorder c)Underwent any prior non-invasive brain stimulation.

结局指标

主要结局

Fugl-Meyer Assessment - Upper extremity

时间窗: Baseline, After 10 sessions of treatment, 12 weeks

次要结局

Modified Modified Ashworth Scale(MMAS), Somatosensory evoked potential(SSEP), Single Photon Emission Computed Tomography(SPECT), Modified Rankin Scale(mRS) and Stroke Specific Quality of Life Scale (SS-QOL)(Baseline, After 10 sessions of treatment, 12 weeks)

研究者

发起方

JIPMER

申办方类型

Research institution

研究点 (1)

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