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Neurofeedback in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03790774
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE December 14, 2018
First Posted Date  ICMJE January 1, 2019
Last Update Posted Date August 29, 2019
Actual Study Start Date  ICMJE June 6, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • EEG spectral content: within-session change in theta band activity [ Time Frame: 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.
  • EEG spectral content: between-session change in theta band activity [ Time Frame: 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 Woodcock-Johnson Tests of Achievement IV: Sentence Reading Fluency [ Time Frame: 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.
  • Change in Letter Cancellation Task: speed [ Time Frame: 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.
  • Change in Letter Cancellation Task: accuracy [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03790774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • The Reading Confidence and Emotions Questionnaire (RCEQ) [ Time Frame: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17) ]
    Participants will answer a series of 22 self-reported likert-scaled questions (each item ranging 1-10) about their confidence and emotions regarding various aspects of reading. This inventory assesses general attitudes about the act of reading, and also perceived changes in reading ability for respondents who have experienced stroke, head injury, or other issues that may have affected their reading ability. Single item scores are not summed for this inventory.
  • Discourse Comprehension Test [ Time Frame: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17) ]
    Participants will read and/or listen to a series of short stories and answer questions about the content of the test passages.
  • Wechsler Adult Intelligence Scale 4th Edition: Digit Span Subtest [ Time Frame: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17) ]
    Participants will listen to a series of digits and attempt to report them back to researchers either in sequence (forwards), in reverse order (backwards), or ordered based on value (sequencing). Digit series will differ in length, starting with two items and increasing in length, up to nine digits. Respondents continue within each trial (forward; backward; sequencing) until they incorrectly respond to two trials in a row for the same sequence length. Total number of points (1 point per correct trial) are tallied per condition: 16 points maximum per condition; 48 points total. This test provides a measure of working memory performance.
  • BCI letter identification task metrics: AUC [ Time Frame: Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase) ]
    EEG signals acquired during the letter viewing task are used to generate on-line estimates of target and non-target EEG profiles. Model fitting accuracy (area under the curve; AUC) will be calculated from a calibration sub-task.
  • BCI letter identification task metrics: ITR [ Time Frame: 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 signals acquired during the letter viewing task are used to generate on-line estimates of target and non-target EEG profiles during a calibration sub-task. Model fitting efficiency (information transfer rate; ITR) will be calculated from a copy-phrase sub-task as a measure of how quickly (bits/minute) the system is able to reverse-identify a target based on the pre-determined EEG profiles.
  • EEG spectral content: within-session change in alpha band activity [ Time Frame: 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 alpha band activity (8-12 Hz) between the start and end of the letter identification task will be quantified.
  • EEG spectral content: between-session change in alpha band activity [ Time Frame: 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 (8-12 Hz) between subsequent study visits will be quantified.
  • EEG spectral content: within-session change in beta band activity [ Time Frame: 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 beta band activity (13-30 Hz) between the start and end of the letter identification task will be quantified.
  • EEG spectral content: between-session change in beta band activity [ Time Frame: 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 (13-30 Hz) between subsequent study visits will be quantified.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurofeedback in Alzheimer's Disease
Official Title  ICMJE Neurofeedback in Alzheimer's Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Behavioral: Neurofeedback
Participants receive intermittent visual and auditory cues to adjust their attentional engagement with a letter identification task.
Study Arms  ICMJE Experimental: 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.
Intervention: Behavioral: Neurofeedback
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consensus diagnosis of possible or probable AD as determined by the OHSU Alzheimer's Disease Center (ADC) weekly meeting
  • Age 50-89 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)
  • 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 in-person hours per week interacting with the primary AD participant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Klee, BS 5034945650 klee@ohsu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03790774
Other Study ID Numbers  ICMJE STUDY00018984
R01DC009834-09S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barry S. Oken, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Barry S Oken Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP