Alzheimer DiseaseNCT03790774
Neurofeedback in Alzheimer's Disease
A study testing Neurofeedback in people with Alzheimer Disease, run by Oregon Health and Science University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
Read the 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
- Being tested
- Neurofeedback
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
Participants receive intermittent visual and auditory cues to adjust their attentional engagement with a letter identification task.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
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.
Measured: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17)
Discourse Comprehension Test
Participants will read and/or listen to a series of short stories and answer questions about the content of the test passages.
Measured: 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
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.
Measured: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17)
BCI letter identification task metrics: AUC
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.
Measured: Once per week for 3-7 weeks (baseline phase); three times per week for 6 weeks (intervention phase)
BCI letter identification task metrics: ITR
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.
Measured: 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 spectral content: within-session change in alpha band activity
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.
Measured: 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 alpha 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 (8-12 Hz) between subsequent study visits will be quantified.
Measured: 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: within-session change in beta band activity
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.
Measured: 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 beta 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 (13-30 Hz) between subsequent study visits will be quantified.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start6 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Aug 2020
Why it stopped: Due to COVID-19 concerns and restrictions in our at-risk population, interactions were halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry S Oken, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790774
- Sponsor's protocol ID
- STUDY00018984
- Other IDs
- R01DC009834-09S1
- Status last verified
- Mar 2021
- First submitted
- 14 Dec 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35754975
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03790774
- Acronym / sponsor ID
- STUDY00018984
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 concerns and restrictions in our at-risk population, interactions were halted.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Behavioral: NeurofeedbackThree times per week, for six weeks, participants will receive biofeedback about the quality of their electroencephalograms (EEG; neurofeedback) during a letter identification task. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackParticipants receive intermittent visual and auditory cues to adjust their attentional engagement with a letter identification task. | Behavioural | Neurofeedback |
Primary outcome
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.
9 secondary outcomes
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)
Discourse Comprehension Test
Time frame: 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
Time frame: Once during screening visit at beginning of study (week 0); once during follow-up visit (week 17)
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)
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 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 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 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 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)
Results and safety
The study was stopped early (reason given: Due to COVID-19 concerns and restrictions in our at-risk population, interactions were halted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 35754975Galvin-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry S Oken principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Alzheimer Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 concerns and restrictions in our at-risk population, interactions were halted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.