Effect of transcranial direct current stimulation (tDCS) on cognitive function in older adults with mild cognitive impairment: a randomized, controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in cognitive function assessed by ACE-H
研究概览
简要总结
A hospital-based, interventional study has been planned as part of this research endeavor. A randomized controlled study would be conducted at Department of Geriatric Mental Health and Department of Psychiatry of a tertiary care hospital of North India. Approval from the Institutional Ethics Committee (IEC) has been received. Adults above 55 years of age qualifying the DSM-5 criteria for Mild neurocognitive disorder will be approached and requested to take part in the study as per study inclusion/ exclusion criteria. The sample size for this study was calculated as 32. Assuming a dropout of 20% the sample size for entire study was estimated as 40.The sample for the study would be identified using purposive sampling technique. The participants would be randomly allocated into two groups based on which there will be single blinding as the participants would not be aware of the allocation. Participants of group A will receive active tDCS (current intensity of 2 mA for 20 minutes with a ramp period of 10 seconds. A total of 10 sessions of active tDCS will be delivered over a period of two weeks following a uniform treatment protocol. Similarly, participants of group B would be delivered a total of 10 sessions of sham tDCS over a period of two weeks following a uniform treatment protocol. Addenbrooke cognitive examination (Hindi version) and WHO-Quality of life scale (brief version) would be applied at baseline and at end of 2nd week and 3rd week. tDCS check list will be applied for monitoring side effects after each tDCS sessions. In case the patient develops any minor adverse effects due to tDCS, conservative management will be done, and patient will be reassured. The study will determine whether tDCS enhances cognitive function and quality of life in older adults with mild NCD,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 55.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Willingness to participate in the study 2 Age 55 years and above 3 Diagnosed with Mild Neurocognitive disorder as per DSM5 criteria.
排除标准
- •1 Uncooperative patients or sensory deficits making assessment difficult 2 Refusal to give written informed consent for participation in the study and tDCS application 3 Medical comorbidities that need immediate attention or patients with terminal illness 4 Family or personal history of epilepsy 5 Any contraindication to tDCS such as History of Head injury or Implanted medical devices or Foreign body in head or eye 6 Scalp Injuries or Skin lesions 7 Presence of psychotic symptoms or suicidal ideations 8 Patients currently in Depression with HAMD score greater than 8 or in Delirium 9 Any other psychiatric comorbidity with exception to tobacco use disorder 10 Patients on procognitive drugs like donepezil or memantine etcectra 11 Current use of other neurostimulation treatments 12 Participants with abnormal thyroid function test or serum Vit B 12 level or Vit D3 level.
结局指标
主要结局
Change in cognitive function assessed by ACE-H
时间窗: At End of 1st week, 2nd week, 3rd week
次要结局
- - ACE-H (total score)(-Change in well-being WHO-Qol-Brief score)
研究者
Shashank Saurabh Sinha
King george medical University