Neurofeedback Intervention for Reading Deficits in Subacute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKessler Foundation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Motor Imagery and Real-Time fMRI Neurofeedback
BehavioralSurvivors 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 Neurofeedback
BehavioralSurvivors 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.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Motor Imagery and Contingent Neurofeedback (NFB)Experimental treatment 1 intervention
Group B: Motor Imagery and Non-contingent Neurofeedback (NFB)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reading Aloud Accuracy
Read aloud 136 words to produce an accuracy score in percent correct.
Time frame
change from baseline at intervention week 1, 2, and 32
fMRI Brain Activity
Whole-brain and region of interest activation and resting state functional connectivity
Time frame
change from baseline at intervention week 1, 2, and 3Secondary outcomes
1
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.
Time frame
change from baseline at 1 week follow up2
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.
Time frame
change from baseline at 1 week follow up3
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.
Time frame
change from baseline at 1 week follow up4
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.
Time frame
change from baseline at 1 week follow upSponsors and contacts
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Source ClinicalTrials.gov