A Randomized, Double-Blinded, Placebo Controlled Pilot Trial of the Feasibility of High Definition Transcranial Direct Current Stimulation and Cognitive Training in Patients With Mild Cognitive Impairment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion
研究概览
简要总结
The primary objective of this project is to assess the feasibility of multi-field, extended HD-tDCS (MFE-HD-tDCS) with simultaneous computerized CT as a viable intervention to improve cognitive function in patients with MCI. This double-blinded, randomized pilot clinical trial of repetitive daily HD-tDCS/sham HD-tDCS, administered in combination with CT to subjects with MCI in 3 monthly blocks of 5 daily sessions for a total of 15 sessions will enroll 8 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blinded
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50-90 years
- •Willing and able to undergo all procedures
- •Retains decisional capacity at initial visit
- •Meets criteria for MCI, amnestic type (Petersen, 2004).
排除标准
- •Significant kidney injury requiring hemodialysis
- •Automatic Internal Cardiac Defibrillator (AICD) or Pacemaker
- •Significant congestive heart failure
- •History of clinically significant ischemic or hemorrhagic stroke, or lacune or infarct considered by radiologist likely to cause or contribute significantly to cognitive symptoms
- •History of thalamic lacunar stroke
- •Modified Hachinski Ischemia Score >4 points
- •History of seizure disorder requiring medication
- •History of brain surgery (for seizure disorder, aneurysms, or benign/malignant tumor)
- •History of HIV/AIDS
- •Severe untreated obstructive sleep apnea
- •Greater than three servings alcohol daily or illicit drug use
- •Major neurologic disorders other than dementia (e.g., MS, ALS)
- •Schizophrenia, bipolar disorder, other serious mental illnesses
- •Other significant medical conditions at investigators' discretion
- •Lack of study partner (Participants are allowed to find a new study partner if the original study partner withdraws)
研究组 & 干预措施
HD-tDCS combined with CT
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months
干预措施: HD-tDCS combined with CT (Device)
sham HD-tDCS combined with CT
sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months
干预措施: sham HD-tDCS combined with CT (Device)
结局指标
主要结局
Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion
时间窗: 6 months
This measure assesses consent rates and treatment completion amongst subjects by assessing the number of subjects who signed consent forms and the number of completed study visits. In this study, 9 subjects provided informed consent. 1 subject was withdrawn. 8 subjects completed treatment. Therefore, only the data from the 8 subjects who completed treatment were analyzed.
次要结局
- Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT(Alzheimer's Disease Cooperative Study, Preclinical Alzheimer's Cognitive Composite (ADCS-PACC) score at 3 and 6 months from baseline.)
- Collect Preliminary Data on the Efficacy of MFE-HD-tDCS in Combination With Computerized CT to Improve Quality of Life in Subjects With MCI(Measure quality of life in subjects over a period of 3 months)
- Effects of MFE-HD-tDCS Combined With Computerized CT on Resting State Brain Network Connectivity(3 months)
研究者
Priyanka Shah-Basak, PhD
Assistant Professor of Neurology
Medical College of Wisconsin