Neurofeedback in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in Woodcock-Johnson Tests of Achievement IV: Sentence Reading Fluency
研究概览
简要总结
This study will evaluate behavioral and electrophysiological changes in a sample of adults with possible or probable Alzheimer's disease (AD), before and after undergoing training using a brain-computer interface (BCI) system with neurofeedback based on electroencephalography (EEG). Participants will repeatedly complete a letter viewing task and receive visual and auditory cues about their brainwaves. The study team hypothesizes that exposure to this EEG-based biofeedback intervention (neurofeedback) will result in a reduction of theta activity (brainwaves in the range of 4-8 Hz). The study team also predicts that exposure to the neurofeedback intervention will result in increased performance on reading, attention, and working memory tasks.
详细描述
This study is a single case research design (SCRD) that will enroll adults with possible or probable AD. Participants will complete a 9 to 13 week testing schedule to deliver a BCI EEG-based neurofeedback intervention. All study visits will occur at participants' place of residence.
Prospective participants will schedule an introductory consent/screening visit with the research team. All participants with AD will be required to enroll with a "study partner" (authorized representative or caretaker) to assist with scheduling and adherence as they progress through the study. Participants who pass screening criteria will continue to participate in the study.
Eligible participants will complete between 3 and 7 weekly baseline assessments, beginning approximately 1 week after the screening visit. In accordance with SCRD standards, performance on outcome measures will be actively monitored during the baseline period. The intervention portion of the study will be triggered sometime during the 3-7 week baseline testing window, once participant performance on the primary outcomes is determined to be stable by the study team.
Following baseline testing, participants will begin a 6-week intervention period with 3 BCI EEG-based neurofeedback sessions per week. A single follow-up visit will be completed approximately one month after the final intervention visit.
Because of the inclusion of adults with decisional impairments in this study, participants with AD will be required to enroll with an accompanying "study partner" (e.g., spouse, caregiver or authorized representative), who will be required to attend all testing visits with the participant and assist with scheduling and adherence. Study partners will be formally enrolled and asked to complete a brief set of questionnaires (e.g., details about the primary participant and their interactions with the primary participant), but they will not receive other testing or intervention materials directly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consensus diagnosis of possible or probable AD as determined by the OHSU Alzheimer's Disease Center (ADC) weekly meeting
- •Age 50-100 years old
- •Possible or probable Alzheimer's disease as indicated by a Global Clinical Dementia Rating score of 0.5 or 1, with language impairment ≥0.5 on the supplemental Clinical Dementia Rating (CDR; form B4, section 2, #10) or similar clinical indicator of language difficulty
- •Passed screening on the adapted BCI screening task presentations on a computer monitor, perceive visual/auditory feedback signals, and tolerate an EEG recording apparatus
- •Reading impairment as measured by Discourse Comprehension Test
排除标准
- •Unstable medication regimen or use of EEG-altering prescription medications
- •Anticipation of major medical interventions which may interrupt study proceedings, including upcoming surgeries
- •Unwilling or unable to follow study protocol, including unstable schedule with frequent trips
- •Note: AD participants must enroll with "study partners" (legally authorized representatives or designated caretakers) in order to participate. To qualify for the study, a study partner must spend an average of ≥10 hours per week interacting with the primary AD participant.
结局指标
主要结局
Change in Woodcock-Johnson Tests of Achievement IV: Sentence Reading Fluency
时间窗: Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)
Participants must read and answer questions about the semantic accuracy of short sentences. Accuracy and speed are recorded.
EEG spectral content: within-session change in theta band activity
时间窗: Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase); once, 4 weeks after the final intervention visit (follow-up)
EEG will be collected during the BCI letter identification task and spectral content will be assessed continuously throughout the task. Changes in theta band activity (4-8 Hz) between the start and end of the letter identification task will be quantified.
Change in Letter Cancellation Task: accuracy
时间窗: Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)
Participants must identify all instances of a target letter (e.g., "Z") on a piece of paper. Accuracy will be quantified as the number of targets omitted (e.g., 2 targets missed).
Change in Forwards and Backwards Letter Span Task
时间窗: Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)
Participants will view a series of letters and attempt to report them back to researchers either in sequence (forwards), or in reverse order (backwards). Letter series will differ in length, starting with two items and increasing in length. Accuracy will be reported and a working memory span will be generated based on performance.
EEG spectral content: between-session change in theta band activity
时间窗: Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase); once, 4 weeks after the final intervention visit (follow-up)
EEG will be collected during the BCI letter identification task and spectral content will be assessed continuously throughout the task. Changes in average theta band activity (4-8 Hz) between subsequent study visits will be quantified.
Change in Letter Cancellation Task: speed
时间窗: Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)
Participants must identify all instances of a target letter (e.g., "Z") on a piece of paper. Speed of completion will be recorded in seconds.
次要结局
- The Reading Confidence and Emotions Questionnaire (RCEQ)(Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17))
- Discourse Comprehension Test(Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17))
- BCI letter identification task metrics: ITR(Weekly during baseline; three times per week during interventionOnce per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase))
- EEG spectral content: within-session change in alpha band activity(Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase); once, 4 weeks after the final intervention visit (follow-up))
- BCI letter identification task metrics: AUC(Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase))
- EEG spectral content: between-session change in alpha band activity(Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase); once, 4 weeks after the final intervention visit (follow-up))
- EEG spectral content: between-session change in beta band activity(Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase); once, 4 weeks after the final intervention visit (follow-up))
- Wechsler Adult Intelligence Scale 4th Edition: Digit Span Subtest(Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17))
- EEG spectral content: within-session change in beta band activity(Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase); once, 4 weeks after the final intervention visit (follow-up))
研究者
Barry S. Oken
Professor and Director
Oregon Health and Science University