Non-invasive brain stimulation for cognitive enhancement in elderly with MCI - a randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hindi Mental status examination score
研究概览
简要总结
Mild Cognitive Impairment (MCI) is a pre-dementia state that has been widely accepted and studied. It is presently understood that interventions in this early stage can prevent the progression to dementia and have been studied by many research groups. Being a transition state between normal aging and dementia which may not always progress to dementia, limited interventions have been tried at this stage. Two interventions that have been previously linked to the improvement of cognition in MCI are transcranial Direct Current Stimulation (tDCS) and repetitive Transcranial Magnetic Stimulation (rTMS). Both of these have been shown by several studies to be effective in improving cognition in elderly people who have MCI. Hence, this research proposal puts forth an exploratory approach to compare the intervention success rates with tDCS and rTMS alone and in combination and duration of the therapeutic effect. For the purpose of analysis, a randomized controlled study is proposed to evaluate the effect of these interventions in MCI. For the proposed study, we plan on recruiting 120 people with MCI. All the participants of this study will be evaluated using global cognitive screening tools such as MoCA, HMSE, and ACE III at the beginning of the study. Then the participants will be randomly allocated to four groups, viz. No intervention, tDCS, rTMS, and sequential intervention with tDCS and RTMS. After completion of a single intervention regimen is completed, all participants will undergo serial assessments using cognitive tests at one week, 4 weeks, 12 weeks, and 24 weeks from the last day of the intervention. From the difference in performance in the cognitive tests, the efficacy of the interventions alone and in combinations, and the duration of effect will be inferred. This research will provide insights contributing to the relevance of tDCS and rTMS as a treatment in older adults with mild cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Satisfying the Manchester Consensus criteria for Mild cognitive impairment or ICD10 criteria for minor neurocognitive disorder.
排除标准
- •No other known neurological or psychiatric disease
- •Presence of metallic implants/pacemaker
- •Present or past history of seizures
- •Use of medicines altering cortical excitability.
结局指标
主要结局
Hindi Mental status examination score
时间窗: 1 week, 4 week, 12 weeks, & 24 weeks after intervention
Addenbrooke Cognitive Examination III score
时间窗: 1 week, 4 week, 12 weeks, & 24 weeks after intervention
Montreal Cognitive Assessment score
时间窗: 1 week, 4 week, 12 weeks, & 24 weeks after intervention
次要结局
- Telephonic administration of Montreal Cognitive Assessment score & Hindi Mental status examination score, and Addenbrooke Cognitive Examination III score(Every 30th day after the last day of intervention)
