Enhancing Gamma Band Response in Mild Cognitive Impairment to Improve Working Memory
概览
- 阶段
- 不适用
- 干预措施
- Neurofeedback
- 疾病 / 适应症
- Mild Cognitive Impairment
- 发起方
- University of California, San Diego
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in Working Memory accuracy
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
Mild cognitive impairment (MCI) has been identified as an early phase of Alzheimer's disease (AD), a neurodegenerative disorder expected to affect 13.9 million Americans by 2060. AD causes a progressive cognitive decline, including problems related to learning and memory, that adversely affects life quality. Treatment intervention at the MCI stage of the disease could potentially slow down the rate at which people may convert from MCI to AD. Increasing evidence suggests that abnormal activity in frontal regions of the brain is associated with cognitive deficits observed in AD. Furthermore, previous research has shown that neurofeedback (NFB) training targeting these regions can improve memory, making it a potential treatment for AD. NFB is a technique where an individual learns to change his/her brain function in a particular direction, once that function has been made accessible through a visual or auditory metaphor. We are proposing a novel, computer-based brain-training program to enhance frontal gamma oscillatory activity in individuals with MCI. Results from this study will build the scientific foundation necessary for larger clinical trials dedicated to improving treatment options and outcomes for patients with MCI.
详细描述
This is a randomized, double-blind, clinical trial to test the efficacy of gamma-neurofeedback (G-NFB) compared to a placebo (P-NFB) in individuals with MCI. 112 consented participants will be randomized to receive G-NFB (n=56) or placebo-NFB (n=56) during 30-45 minute sessions twice per week for 12 weeks (24 total sessions). Memory and other cognitive domains will be measured using paper and pencil and computerized tests every 4 weeks during the study and at 4 weeks post completion of study.
研究者
Fiza Singh
Associate Professor of Psychiatry
University of California, San Diego
入排标准
入选标准
- •Meet criteria for mild cognitive impairment (MCI).
- •Living independently.
- •Literate in English.
- •Competent to participate in the informed consent process and provide voluntary informed consent.
排除标准
- •Frontal temporal dementia
- •Active alcohol or substance use disorder within the past year.
- •Brain cancer
- •Stroke within the last 2 years
- •Anti-epileptic medication
- •Prior head injury involving loss of consciousness
- •Seizure disorder
- •Use of medications likely to affect cognitive function (cf. donepezil, memantine). We will not exclude for other medications but will examine their effects and include medications as covariates as appropriate (e.g., presence v. absence; anticholinergic load).
- •The potential benefits of the study do not outweigh the potential risks of the study, as determined by the PI.
研究组 & 干预措施
Active Treatment
Subjects will be given a choice of videos consisting of still images set to music. Whether the video progresses and music continues to play will depend on the subject's ability to maintain frontal gamma oscillatory activity within a prespecified range. Over successive weeks, the parameters for positive feedback (music and video progression) will become incrementally more difficult.
干预措施: Neurofeedback
Placebo
Video and music progression will be random and will not depend on brain activity. Any progression will be by random chance alone.
干预措施: Placebo
结局指标
主要结局
Change in Working Memory accuracy
时间窗: From baseline to 12 weeks of treatment
Change in the computerized test, N-back will be used to measure working memory.
次要结局
- Durability of Change in Working Memory accuracy(From baseline to 4weeks post end of study)
- Durability of Gamma Band Response(From baseline to 4weeks post end of study)
- Change in Gamma Band Response(From baseline to 12 weeks of treatment)