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Neurofeedback Intervention for Reading Deficits in Subacute Stroke

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04875936
Acronym
ReadingNFB
Enrollment
28
Registered
2021-05-06
Start date
2023-04-03
Completion date
2027-06-30
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslexia, Acquired, Stroke

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.

Interventions

BEHAVIORALMotor Imagery and Real-Time fMRI Neurofeedback

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.

BEHAVIORALMotor Imagery and Sham fMRI Neurofeedback

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.

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will be masked to the nature of real-time fMRI neurofeedback they will receive: contingent or non-contingent.

Intervention model description

Participants are randomly assigned to one of 2 groups

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

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)

Design outcomes

Primary

MeasureTime frameDescription
Reading Aloud Accuracychange from baseline at intervention week 1, 2, and 3Read aloud 136 words to produce an accuracy score in percent correct.
fMRI Brain Activitychange from baseline at intervention week 1, 2, and 3Whole-brain and region of interest activation and resting state functional connectivity

Secondary

MeasureTime frameDescription
Reading Comprehension Battery for Aphasia (RCBA-2)change from baseline at 1 week follow upLetter, 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) Bedsidechange from baseline at 1 week follow upA 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 upA 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 testchange from baseline at 1 week follow upTouch-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 upA 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 evaluationbaseline and 1 week follow upAn 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026