Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Cognitive Assessment Batteries
研究概览
简要总结
The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in older adults with and without cognitive impairment. The main questions it aims to answer are:
- whether it is possible to restore various cognitive functions in older adults by delivering theta burst stimulation (TBS), a form of transcranial magnetic stimulation, and
- whether closed-loop TBS is able to induce therapeutic benefits that outperform open-loop TBS.
Participants play a cognitive video game while a brain-computer interface (BCI) analyzes their electroencephalogram (EEG) signals and decodes the presence or absence of the contingent negative variation (CNV) potential, a marker of cognitive control. The BCI triggers TBS when its outputs indicate that the participant is not engaged properly in the video game.
Researchers will compare the effects of closed-loop and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older adults
- •Ages between 60 to 90 years
- •Good general health
- •Normal or corrected vision
- •Completed elementary school education or able to understand middle school level experiment instructions
- •Self reports cognitive complaints
- •Cognitively normal young adults
- •Ages between 18 to 35 years
- •Good general health
- •Normal or corrected vision
- •Completed elementary school education or able to understand middle school level experiment instructions
排除标准
- •Self-report of neurological or psychiatric diseases that could be contraindicated for TMS (e.g., personal history of epilepsy/seizure brain damage, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).
- •Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).
- •Factors hindering EEG acquisition and rTMS delivery (e.g., skin infection, wounds, dermatitis, unable to access the scalp of the participant (e.g., unremovable wig).
- •Current participation in amyloid infusion treatment for Alzheimer's disease.
- •Do not have the capacity to provide informed consent and does not have a Legally Authorized Representative.
- •Resting motor threshold below the power limit in the laboratory. (Will be check on the first visit)
研究组 & 干预措施
Closed-Loop TBS
干预措施: Closed-loop TBS (Device)
Open-Loop TBS
干预措施: Open-loop TBS (Device)
结局指标
主要结局
Cognitive Assessment Batteries
时间窗: Up to 8 weeks after intervention
NIH Toolbox - Cognition Battery: A computerized battery assessing multiple cognitive domains. The primary metric for all subtests is the age- and education-adjusted T-score (normative mean = 50, standard deviation = 10). Includes: Dimensional Change Card Sort, Face-Name Associative Memory Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, Rey Auditory Verbal Learning Test, Pattern Comparison Processing Speed Test
次要结局
- Accuracy of the BCI classifier output(Up to 8 weeks after intervention)
- Behavioral performance of the video game task(Up to 8 weeks after intervention)
- N-Back Task(Up to 8 weeks after intervention.)
- Affective Flexibility Task(Up to 8 weeks after intervention)
- Perseverative Thinking Questionnaire(Up to 8 weeks after intervention)
- Hamilton Depression Rating Scale(Up to 8 weeks after intervention)
研究者
Jose del R. Millan
Professor
University of Texas at Austin