Neurofeedback in Alzheimer's Disease

NCT03790774 | Terminated

• 2 other identifiers: STUDY00018984R01DC009834-09S1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (6)

• EEG spectral content: within-session change in theta band activity

  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.

  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 theta band activity

  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.

  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)

• Change in Woodcock-Johnson Tests of Achievement IV: Sentence Reading Fluency

  Participants must read and answer questions about the semantic accuracy of short sentences. Accuracy and speed are recorded.

  Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)

• Change in Letter Cancellation Task: speed

  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.

  Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)

• Change in Letter Cancellation Task: accuracy

  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).

  Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)

• Change in Forwards and Backwards Letter Span Task

  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.

  Once per week for 9-13 weeks (throughout baseline and intervention phases); once, 4 weeks after the final intervention visit (follow-up)

Secondary Outcomes (9)

• 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)

• 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)

• BCI letter identification task metrics: AUC

  Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase)

• 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)

Study Arms (1)

Neurofeedback

EXPERIMENTAL

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

Behavioral: Neurofeedback

Interventions

Neurofeedback BEHAVIORAL

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

Neurofeedback

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 35754975 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Barry S Oken

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 2, 2019
• Study Start: June 6, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

US (1)