Neurofeedback in Alzheimer's Disease

NCT ID: NCT03790774

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2020-08-01

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Neurofeedback

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

Group Type: EXPERIMENTAL

Neurofeedback

Intervention Type: BEHAVIORAL

Participants receive intermittent visual and auditory cues to adjust their attentional engagement with a letter identification task.

Interventions

Neurofeedback

Participants receive intermittent visual and auditory cues to adjust their attentional engagement with a letter identification task.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Barry S. Oken

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry S Oken

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35754975 (View on PubMed)

Other Identifiers

R01DC009834-09S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00018984

Identifier Type: -

Identifier Source: org_study_id