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NCT Number: NCT04875936

Neurofeedback Intervention for Reading Deficits in Subacute Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Dyslexia Dyslexia, Acquired Language Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Specific Learning Disorder Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location status: Recruiting

Location contact

Olga Boukrina, Ph.D.

CONTACT

[email protected]

9733243587

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Motor Imagery and Real-Time fMRI Neurofeedback

Behavioral

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.

Motor Imagery and Sham fMRI Neurofeedback

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Neuro evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

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

Acronym: ReadingNFB

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 6, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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