Neurofeedback in Alzheimer's Disease

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Alzheimer Disease

Treatments: Behavioral: Neurofeedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03790774

STUDY00018984

R01DC009834-09S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Neurofeedback

Experimental group

Description:

Three times per week, for six weeks, participants will receive biofeedback about the quality of their electroencephalograms (EEG; neurofeedback) during a letter identification task.

Treatment:

Behavioral: Neurofeedback