Clinical trial NCT03790774: Neurofeedback in Alzheimer's Disease
Official title: Neurofeedback in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2019-01-02
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: EEG spectral content: within-session change in theta band activity
timeFrame: 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)
measure: EEG spectral content: between-session change in theta band activity
timeFrame: 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)
measure: Change in Woodcock-Johnson Tests of Achievement IV: Sentence Reading Fluency
timeFrame: Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)
measure: Change in Letter Cancellation Task: speed
timeFrame: Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)
measure: Change in Letter Cancellation Task: accuracy
timeFrame: Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)
measure: Change in Forwards and Backwards Letter Span Task
timeFrame: Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)
Secondary outcomes:
measure: The Reading Confidence and Emotions Questionnaire (RCEQ)
timeFrame: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17)
measure: Discourse Comprehension Test
timeFrame: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17)
measure: Wechsler Adult Intelligence Scale 4th Edition: Digit Span Subtest
timeFrame: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17)
measure: BCI letter identification task metrics: AUC
timeFrame: Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase)
measure: BCI letter identification task metrics: ITR
timeFrame: 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)
measure: EEG spectral content: within-session change in alpha band activity
timeFrame: 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)
measure: EEG spectral content: between-session change in alpha band activity
timeFrame: 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)
measure: EEG spectral content: within-session change in beta band activity
timeFrame: 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)
measure: EEG spectral content: between-session change in beta band activity
timeFrame: 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)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Barry S Oken
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galvin-McLaughlin D, Klee D, Memmott T, Peters B, Wiedrick J, Fried-Oken M, Oken B; Consortium for Accessible Multimodal Brain-Body Interfaces (CAMBI). Methodology and preliminary data on feasibility of a neurofeedback protocol to improve visual attention to letters in mild Alzheimer's disease. Contemp Clin Trials Commun. 2022 Jun 13;28:100950. doi: 10.1016/j.conctc.2022.100950. eCollection 2022 Aug.