- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04875936
Neurofeedback Intervention for Reading Deficits in Subacute Stroke (ReadingNFB)
May 1, 2023 updated by: Olga Boukrina, Kessler Foundation
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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West Orange, New Jersey, United States, 07052
- Recruiting
- Kessler Foundation
-
Contact:
- Olga Boukrina, Ph.D.
- Phone Number: 973-324-3587
- Email: oboukrina@kesslerfoundation.org
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- First-ever left-hemisphere stroke < 10 weeks 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motor Imagery and Contingent Neurofeedback (NFB)
This group will receive real-time fMRI NFB on the bases of participant's own brain activity
|
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.
|
Sham Comparator: Motor Imagery and Non-contingent Neurofeedback (NFB)
This group will receive group will receive fMRI NFB based on another participant's brain activity
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
change from baseline at intervention week 1, 2, and 3
|
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
|
change from baseline at intervention week 1, 2, and 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading Comprehension Battery for Aphasia (RCBA-2)
Time Frame: change from baseline at 1 week follow up
|
Letter, word, sentence, paragraph and text-level reading comprehension test designed for aphasia.
Score range 0-100, higher scores correspond to better reading ability.
|
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
|
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.
|
change from baseline at 1 week follow up
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Boston Naming Test (BNT-short)
Time Frame: change from baseline at 1 week follow up
|
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.
|
change from baseline at 1 week follow up
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Palm Trees and Pyramids test
Time Frame: change from baseline at 1 week follow up
|
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.
|
change from baseline at 1 week follow up
|
Geriatric Depression Scale (GDS)
Time Frame: change from baseline at 1 week follow up
|
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.
|
change from baseline at 1 week follow up
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Neuro evaluation
Time Frame: baseline and 1 week follow up
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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.
|
baseline and 1 week follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2023
Primary Completion (Anticipated)
June 30, 2026
Study Completion (Anticipated)
June 30, 2026
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
May 3, 2021
First Posted (Actual)
May 6, 2021
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 1, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodevelopmental Disorders
- Language Disorders
- Communication Disorders
- Learning Disabilities
- Stroke
- Dyslexia
- Dyslexia, Acquired
Other Study ID Numbers
- R-1147-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Data may be shared after the acceptance for publication of the main findings of the study.
IPD Sharing Access Criteria
Data may be shared upon request and following the establishment of a data sharing agreement, that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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