StrokeReadingNFBNCT04875936
Neurofeedback Intervention for Reading Deficits in Subacute Stroke
A study testing Motor Imagery and Real-Time fMRI Neurofeedback in people with Stroke and Dyslexia, Acquired, run by Kessler Foundation at 1 site in United States.
Trial summary
The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Dyslexia, Acquired
- What is being tested?
- Motor Imagery and Real-Time fMRI Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-ever left-hemisphere stroke < 3 months prior to study recruitment or healthy volunteer
- Age: 18 - 80 years old
- Fluent and literate in English prior to stroke
- Reading deficits, defined as >3 errors on the Paragraphs test (subtests VIII, IX) of the Reading Comprehension Battery for Aphasia-2nd ed. (RCBA-2) in keeping with the healthy control accuracy criterion of 86-100% correct.
Who cannot join
- Inability to consent or complete study tasks
- Inability to undergo MRI (e.g., pregnancy, non-MRI compatible implants, claustrophobia)
- A history of prior neurological disease (e.g., brain tumor, Alzheimer's disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Olga Boukrina, Ph.D., 9733243587, oboukrina@kesslerfoundation.org
About this study
Official title: Rehabilitation of Reading Deficits in Subacute Stroke Using Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery
The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.
- Conditions
- Stroke, Dyslexia, Acquired
- Being tested
- Motor Imagery and Real-Time fMRI Neurofeedback, Motor Imagery and Sham fMRI Neurofeedback
- Medical subject headings
- Stroke, Dyslexia, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery and Real-Time fMRI NeurofeedbackBehavioural
Survivors of left-hemisphere stroke (<10 weeks post-stroke) or healthy volunteers will use right-hand motor imagery coupled with fMRI neurofeedback to help them re-engage the left hemisphere by shifting brain activation leftward relative to the initial left-right asymmetry. Following group assignment, participants will perform a motor imagery task and complete 3 sessions of motor imagery and reading tasks in the MRI scanner over 3 weeks. During the MRI sessions they will receive real time neurofeedback about how well they are engaging the left side of their brain compared to the right side. They will also practice the same task for 30 min a day as homework using the most effective motor imagery strategy that worked for them in the MRI scanner.
Motor Imagery and Sham fMRI NeurofeedbackBehavioural
Survivors of left-hemisphere stroke (<10 weeks post-stroke) or healthy volunteers will practice right-hand motor imagery coupled with sham fMRI neurofeedback. As the experimental group, participants will perform a motor imagery task and complete 3 sessions of motor imagery and reading tasks in the MRI scanner over 3 weeks. However, during the MRI sessions they will receive sham neurofeedback on the basis of another participant's brain activity. Like the experimental group, they will also practice the same task for 30 min a day as homework.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery and Contingent Neurofeedback (NFB) | Experimental | This group will receive real-time fMRI NFB on the bases of participant's own brain activity Receives: Behavioral: Motor Imagery and Real-Time fMRI Neurofeedback |
| Motor Imagery and Non-contingent Neurofeedback (NFB) | Sham comparator | This group will receive group will receive fMRI NFB based on another participant's brain activity Receives: Behavioral: Motor Imagery and Sham fMRI Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading Aloud Accuracy
Read aloud 136 words to produce an accuracy score in percent correct.
Measured: change from baseline at intervention week 1, 2, and 3
fMRI Brain Activity
Whole-brain and region of interest activation and resting state functional connectivity
Measured: change from baseline at intervention week 1, 2, and 3
Secondary outcomes (6)
Reading Comprehension Battery for Aphasia (RCBA-2)
Letter, word, sentence, paragraph and text-level reading comprehension test designed for aphasia. Score range 0-100, higher scores correspond to better reading ability.
Measured: change from baseline at 1 week follow up
Western Aphasia Battery-Revised (WAB-R) Bedside
A bedside assessment for language impairments in aphasia. Scores range from 0 to 80 for the Bedside Language Score and higher scores represent better language ability.
Measured: change from baseline at 1 week follow up
Boston Naming Test (BNT-short)
A brief picture naming test designed to identify word finding difficulties. Score ranges from 0 to 15, with higher scores corresponding to better picture naming ability.
Measured: change from baseline at 1 week follow up
Palm Trees and Pyramids test
Touch-screen computer tests of semantics, phonology, and orthography. The semantics task is to choose one of two examples at the bottom of the screen that matches the target at the top in meaning. The phonology task is to select a rhyme of the target in a similar fashion. These tests have a word and picture versions. The orthography task is to choose a letter string that more closely resembles a word. Each subtest accuracy ranges from 0 to 60 items, with higher scores representing better function.
Measured: change from baseline at 1 week follow up
Geriatric Depression Scale (GDS)
A self-report assessment of depression to be used as covariate where appropriate. Scores range 0-30, with higher scores representing worse self-ratings of depression.
Measured: change from baseline at 1 week follow up
Neuro evaluation
An in-house test of motor and cognitive function, administered by a qualified clinician. The test includes observational checklists, testing 9 qualitative parameters: mental status, cranial nerves, motor function, sensory function, reflexes, cerebellar function, gait and stance, behavior during testing and any other observations.
Measured: baseline and 1 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start3 Apr 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of 2 groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Boukrina, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875936
- Sponsor's protocol ID
- R-1147-21
- Acronym
- ReadingNFB
- Status last verified
- May 2026
- First submitted
- 29 Apr 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated in this project may be shared in accordance with the funding agency (NIH) and site organization (Kessler Foundation) policies, as well as the Notice of Privacy of Practices and Informed Consent documents signed by each participant in the study. In case data are shared, they will be de-identified, such that no link can be made to the individual participant. To prevent the possibility of deductive disclosure of participants through brain scans and the association with the rehabilitation hospital, data and associated documentation will be made available to users only under a data-sharing agreement.
Publications
Boukrina O, Yamin A, Yue GH, Kong Y, Koush Y. Feasibility Randomized Controlled Trial of Real-Time fMRI Neurofeedback for Reading Rehabilitation in Aphasia. Stroke. 2026 Jun;57(6):1535-1548. doi: 10.1161/STROKEAHA.125.054877. Epub 2026 Apr 10.
PubMed 41958417Boukrina O, Yamin A, Yue GH, Kong Y, Koush Y. Feasibility of real-time fMRI neurofeedback for rehabilitation of reading deficits in aphasia. medRxiv [Preprint]. 2025 Jan 5:2025.01.03.25319980. doi: 10.1101/2025.01.03.25319980.
PubMed 39802782
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Reading Deficits in Subacute Stroke Using Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery
- ClinicalTrials.gov ID
- NCT04875936
- Acronym / sponsor ID
- ReadingNFB / R-1147-21
- Conditions
- Stroke, Dyslexia, Acquired
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 May 2021 (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.
The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of 2 groups
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery and Contingent Neurofeedback (NFB) | Experimental | Behavioral: Motor Imagery and Real-Time fMRI NeurofeedbackThis group will receive real-time fMRI NFB on the bases of participant's own brain activity |
| Motor Imagery and Non-contingent Neurofeedback (NFB) | Sham comparator | Behavioral: Motor Imagery and Sham fMRI NeurofeedbackThis group will receive group will receive fMRI NFB based on another participant's brain activity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First-ever left-hemisphere stroke < 3 months prior to study recruitment or healthy volunteer
- Age: 18 - 80 years old
- Fluent and literate in English prior to stroke
- Reading deficits, defined as >3 errors on the Paragraphs test (subtests VIII, IX) of the Reading Comprehension Battery for Aphasia-2nd ed. (RCBA-2) in keeping with the healthy control accuracy criterion of 86-100% correct.
Key exclusion criteria (3 listed)
- Inability to consent or complete study tasks
- Inability to undergo MRI (e.g., pregnancy, non-MRI compatible implants, claustrophobia)
- A history of prior neurological disease (e.g., brain tumor, Alzheimer's disease)
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 |
|---|---|---|
| Motor Imagery and Real-Time fMRI NeurofeedbackSurvivors of left-hemisphere stroke (<10 weeks post-stroke) or healthy volunteers will use right-hand motor imagery coupled with fMRI neurofeedback to help them re-engage the left hemisphere by shifting brain activation leftward relative to the initial left-right asymmetry. Following group assignment, participants will perform a motor imagery task and complete 3 sessions of motor imagery and reading tasks in the MRI scanner over 3 weeks. During the MRI sessions they will receive real time neurofeedback about how well they are engaging the left side of their brain compared to the right side. They will also practice the same task for 30 min a day as homework using the most effective motor imagery strategy that worked for them in the MRI scanner. | Behavioural | Motor Imagery and Contingent Neurofeedback (NFB) |
| Motor Imagery and Sham fMRI NeurofeedbackSurvivors of left-hemisphere stroke (<10 weeks post-stroke) or healthy volunteers will practice right-hand motor imagery coupled with sham fMRI neurofeedback. As the experimental group, participants will perform a motor imagery task and complete 3 sessions of motor imagery and reading tasks in the MRI scanner over 3 weeks. However, during the MRI sessions they will receive sham neurofeedback on the basis of another participant's brain activity. Like the experimental group, they will also practice the same task for 30 min a day as homework. | Behavioural | Motor Imagery and Non-contingent Neurofeedback (NFB) |
Primary outcome
Reading Aloud Accuracy
Time frame: change from baseline at intervention week 1, 2, and 3
Read aloud 136 words to produce an accuracy score in percent correct.
fMRI Brain Activity
Time frame: change from baseline at intervention week 1, 2, and 3
Whole-brain and region of interest activation and resting state functional connectivity
6 secondary outcomes
Reading Comprehension Battery for Aphasia (RCBA-2)
Time frame: change from baseline at 1 week follow up
Western Aphasia Battery-Revised (WAB-R) Bedside
Time frame: change from baseline at 1 week follow up
Boston Naming Test (BNT-short)
Time frame: change from baseline at 1 week follow up
Palm Trees and Pyramids test
Time frame: change from baseline at 1 week follow up
Geriatric Depression Scale (GDS)
Time frame: change from baseline at 1 week follow up
Neuro evaluation
Time frame: baseline and 1 week follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 41958417Boukrina O, Yamin A, Yue GH, Kong Y, Koush Y. Feasibility Randomized Controlled Trial of Real-Time fMRI Neurofeedback for Reading Rehabilitation in Aphasia. Stroke. 2026 Jun;57(6):1535-1548. doi: 10.1161/STROKEAHA.125.054877. Epub 2026 Apr 10.
- Derived from this study: PubMed 39802782Boukrina O, Yamin A, Yue GH, Kong Y, Koush Y. Feasibility of real-time fMRI neurofeedback for rehabilitation of reading deficits in aphasia. medRxiv [Preprint]. 2025 Jan 5:2025.01.03.25319980. doi: 10.1101/2025.01.03.25319980.
- Individual participant dataSharing planned: Yes. Data generated in this project may be shared in accordance with the funding agency (NIH) and site organization (Kessler Foundation) policies, as well as the Notice of Privacy of Practices and Informed Consent documents signed by each participant in the study. In case data are shared, they will be de-identified, such that no link can be made to the individual participant. To prevent the possibility of deductive disclosure of participants through brain scans and the association with the rehabilitation hospital, data and associated documentation will be made available to users only under a data-sharing agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery and Real-Time fMRI Neurofeedback in people with Stroke and Dyslexia, Acquired, run by Kessler Foundation 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading Aloud Accuracy (time frame: change from baseline at intervention week 1, 2, and 3). The study lists 2 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 NCT04875936, which also lists 2 linked publications.
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 8 May 2026.