Optimization and efficacy of Non–Invasive Brain stimulation on Cognitive and Motor function in stroke patients - A Randomised control trial study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Improvement in cognitive and motor function
研究概览
简要总结
Background: Stroke is one of the main causes of disability worldwide, affecting the patient’s motor, sensory, and cognitive skills. Non-invasive brain stimulation treatments such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) have been found to help in rehabilitation of stroke victims. However, there is a need to optimize the parameters of these techniques to maximize their efficacy in stroke rehabilitation.
**Novelty:**The proposed study aims to explore the optimization of non-invasive brain stimulation parameters for stroke rehabilitation, which is an underexplored area of research. The study will focus on the comparison of the both the techniques, which among them is more effective in improving motor and cognitive function in stroke patients. And also to understand which of the technique is more cost effective. Above all this study would explore what is the efficacy of the both the techniques by studying the long term follow up.
**Objectives:**The main objectives of the study are:
To determine the optimal parameters for rTMS and tDCS in stroke rehabilitation, including frequency, intensity, and duration of stimulation.
To compare the effectiveness of rTMS and tDCS in improving cognitive and motor functions in stroke patients.
To explore the efficacy of rTMS and tDCS by studying the long-term effects of rTMS and tDCS on cognitive and motor functions in stroke patients.
**Methods:**The study is a randomised control trial study. Participants will be recruited from AIIMS Deoghar, local hospitals and rehabilitation centres at Deoghar district. Inclusion criteria will include a diagnosis of stroke, aged between 18 and 65 years, and a score of ≤ 25 on the Montreal Cognitive Assessment (MoCA) test and Fugl Meyer test for Motor function assessment with mild to moderate stroke condition. A total of 128 study participants will be selected for the study. Participants will be randomly assigned to one of four groups: active rTMS, active tDCS, sham interventional group of both techniques and standard therapy alone. The active groups will receive 20 minutes of stimulation daily for 6 weeks. While the sham groups will receive a placebo stimulation of 20 mins . The primary outcome measures will be the change in the MoCA score and the Fugl-Meyer assessment (FMA) of cognitive and motor function respectively. Data analysis will be conducted using repeated-measures analysis of variance (ANOVA) and post-hoc comparisons.
**Expected outcome:**The proposed study is expected to contribute to the optimization of non-invasive brain stimulation parameters for stroke rehabilitation. The study may lead to the development of new and more effective rehabilitation strategies for stroke patients. The results of this study will also help to determine the long-term effects(efficacy) of non-invasive brain stimulation on cognitive and motor function in stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •First ever and haemorrhagic stroke/ischemic stroke with responsible lesions located in unilateral basal ganglia and/or corona radiate region confirmed by a brain computed tomography or magnetic resonance imaging 2)Stable vital signs, no deterioration of neurological symptoms 3)Post stroke duration of 1 month to 6 months 4)Aged between 18 and 65 years (both sexes) 5)Fugl Meyer Assessment score to assess motor skills more than 50 6)With cognitive disability with MoCA score of less than 25 7)Stroke patients without severe aphasia, visual or hearing impairment so as to be capable of fulfilling the study protocol.
排除标准
- •Patients with metal implants in the body , 2)History of seizures or family history, 3)Severe cardiopulmonary disease and multiple organ failure, 4)Malignant tumours, and 5)Severe mental illness, 6)Previous history of encephalitis, 7)Brain trauma, 8)Alzheimer’s disease and dementia, t 9)Hose with severe visual, hearing or communication impairment.Â.
结局指标
主要结局
Improvement in cognitive and motor function
时间窗: The cognitive and motor function of the subjects will be assessed at 3 different point of time. | 1. Before the intervention, that is the baseline status. | 2. During the intervention ,1st day of 4th week | 3. During the completion of intervention date ,that is the 6th week (last day).
次要结局
- Improvement in cognitive and motor function in stroke patients(6 months (after the intervention))
研究者
Ayesha Juhi
All India Institute of Medical Sciences, Deoghar