Study of Effectiveness of transcranial direct current stimulation (tDCS) on cognitive function in patients of Alzheimer's Disease: A double blind sham controlled randomized trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- SELF
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Effect of tDCS on cognitive function in patients of alzheimers disease
研究概览
简要总结
Purpose of this study is it will be one of the first studies to evaluate tDCS(transcranial direct current stimulation) in AD(Alzheimer’s Disease) patients in Odisha using a double-blind, sham-controlled design.
Addressing population-specific factors, it provides novel insights into tDCS’s applicability in Indian contexts, guiding future clinical and policy decisions.
Hypothesis: Active tDCS improves cognitive function in AD patients compared to sham tDCS, with negligible adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •A : Patients diagnosed with Alzheimer’s disease according to standardized diagnostic criteria (ICD-11).
- •B : Patients who will give informed consent.
- •C : Patients between the ages of 60 years and 80 years.
- •D : Patients on Donepezil for a minimum of 4 weeks with MMSE Score between 18-23.
排除标准
- •A : Age below 60 years and above 80 years B : Patients with a history of significant neurological disorders other than dementia (e.g. Traumatic Head Injury, epilepsy).
- •C : Individuals with severe psychiatric conditions (e.g., schizophrenia, Mental retardation, Mood Disorders) D : Individual who was previously diagnosed with Wernicke’s Koraskoff Psychosis E : Those with contraindications to tDCS (transcranial direct current stimulation), such as implanted electronic devices.
- •F : Inability to undergo the required cognitive assessments due to language barriers, severe sensory impairments, or other factors affecting comprehension or communication.
结局指标
主要结局
Effect of tDCS on cognitive function in patients of alzheimers disease
时间窗: At Baseline, after 4 weeks [total 40 sessions (twice daily 5 days per week x 4 week)] and after 8 week.
Scales : ACE-III,MMSE,CGI and side effects
时间窗: At Baseline, after 4 weeks [total 40 sessions (twice daily 5 days per week x 4 week)] and after 8 week.
次要结局
未报告次要终点
研究者
Bhavikkumar Maheshbhai Patel
INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL