Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI.
研究概览
简要总结
The project is a placebo-controlled study that aims to use closed-loop transcranial alternating current stimulation (tACS) to study patients with symptoms of mild cognitive impairment which is likely due to Alzheimer's disease or another form of dementia (AD-MCI). Patients will undergo an EEG and complete some questionnaires and computer tasks during each study visit. The project has the following aims and hypotheses: 1.) To determine the impact of closed-loop 40 Hz tACS on the entrainment of natural gamma rhythms in patients with AD-MCI, 2.) To determine the impact of closed-loop 40 Hz tACS on cognitive performance in patients with AD-MCI, and 3.) To assess the relationship between baseline neurodegenerative burden and impact of tACS. [exploratory]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported)
- •50-80 years of age
- •English native speakers
排除标准
- •Known presence of a structural brain lesion (e.g., tumor, cortical infarct)
- •Acute or decompensated active medical conditions, including cancer, cardiovascular disease, stroke, congestive heart failure
- •Active hematological, renal, pulmonary, endocrine or hepatic disorders
- •Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
- •tACS contraindications (lesions in the scalp, history of seizures)
研究组 & 干预措施
MCI Subjects
干预措施: tACS device (Device)
Healthy Controls
干预措施: tACS device (Device)
结局指标
主要结局
Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI.
时间窗: After a single stimulation session (30 minutes).
Measured using closed loop 40 Hertz tACS device
Changes in cognitive performance in patients with AD-MCI.
时间窗: After a single stimulation session (30 minutes).
Measured using Rey Auditory Verbal Learning Task (RAVLT) which is broken into 6 blocks with each block including a list of 15 words and higher word remembrance in each block indicates a better outcomes, and Face-Name Association Task (FNAT) task where a higher score of matching face to name (out of 60 trials) indicates a better outcome
Changes in gamma power on cognition in patients with AD-MCI including the effect of baseline neurodegenerative burden/biomarkers. [exploratory]
时间窗: After a single stimulation session (30 minutes).
Measured using Rey Auditory Verbal Learning Task (RAVLT) which is broken into 6 blocks with each block including a list of 15 words and higher word remembrance in each block indicates a better outcomes, and Face-Name Association Task (FNAT) task where a higher score of matching face to name (out of 60 trials) indicates a better outcome, any MRI/PET scans provided prior to study involvement, and changes in gamma power using closed loop 40 Hertz tACS device
次要结局
未报告次要终点
研究者
Joan A Camprodon, MD MPH PhD
Chief, Division of Neuropsychiatry and Neuromodulation
Massachusetts General Hospital