Neurofeedback Intervention for Reading Deficits in Subacute Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Rehabilitation of Reading Deficits in Subacute Stroke Using Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery

Conditions
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Stroke, Dyslexia, Acquired

Intervention / Treatment
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* Behavioral: Motor Imagery and Real-Time fMRI Neurofeedback
* Behavioral: Motor Imagery and Sham fMRI Neurofeedback


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to one of 2 groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor Imagery and Contingent Neurofeedback (NFB)<br>This group will receive real-time fMRI NFB on the bases of participant's own brain activity | Behavioral: Motor Imagery and Real-Time fMRI Neurofeedback<br>* 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.<br>|
| Sham Comparator: Motor Imagery and Non-contingent Neurofeedback (NFB)<br>This group will receive group will receive fMRI NFB based on another participant's brain activity | Behavioral: Motor Imagery and Sham fMRI Neurofeedback<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading Aloud Accuracy | 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 | 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) | 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 | 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 | 
| 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. | 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. | 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. | 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. | baseline and 1 week follow up |