Neurofeedback Intervention for Reading Deficits in Subacute Stroke
- Conditions
- Dyslexia, AcquiredStroke
- Interventions
- Behavioral: Motor Imagery and Sham fMRI NeurofeedbackBehavioral: Motor Imagery and Real-Time fMRI Neurofeedback
- Registration Number
- NCT04875936
- Lead Sponsor
- Kessler Foundation
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Motor Imagery and Non-contingent Neurofeedback (NFB) Motor Imagery and Sham fMRI Neurofeedback This group will receive group will receive fMRI NFB based on another participant's brain activity Motor Imagery and Contingent Neurofeedback (NFB) Motor Imagery and Real-Time fMRI Neurofeedback This group will receive real-time fMRI NFB on the bases of participant's own brain activity
- Primary Outcome Measures
Name Time Method Reading Aloud Accuracy 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 change from baseline at intervention week 1, 2, and 3 Whole-brain and region of interest activation and resting state functional connectivity
- Secondary Outcome Measures
Name Time Method Reading Comprehension Battery for Aphasia (RCBA-2) 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.
Western Aphasia Battery-Revised (WAB-R) Bedside 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.
Boston Naming Test (BNT-short) 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.
Palm Trees and Pyramids test 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.
Geriatric Depression Scale (GDS) 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.
Neuro evaluation baseline and 1 week follow up 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.
Trial Locations
- Locations (1)
Kessler Foundation
🇺🇸West Orange, New Jersey, United States