Menu
Recruiting NCT04875936

Neurofeedback Intervention for Reading Deficits in Subacute Stroke

No phase Interventional Stroke Dyslexia, Acquired

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motor Imagery and Real-Time fMRI Neurofeedback, Motor Imagery and Sham fMRI Neurofeedback.
Who it may be relevant to
Registry conditions: Stroke, Dyslexia, Acquired. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Behavioral Motor 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 neuro
  • Behavioral Motor 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 practi

Primary outcome measures

  • Reading Aloud Accuracy [Time frame: change from baseline at intervention week 1, 2, and 3]
  • fMRI Brain Activity [Time frame: change from baseline at intervention week 1, 2, and 3]
Secondary outcome measures (6)
  • Reading Comprehension Battery for Aphasia (RCBA-2) [Time frame: change from baseline at 1 week follow up]
  • Western Aphasia Battery-Revised (WAB-R) Bedside [Time frame: change from baseline at 1 week follow up]
  • Boston Naming Test (BNT-short) [Time frame: change from baseline at 1 week follow up]
  • Palm Trees and Pyramids test [Time frame: change from baseline at 1 week follow up]
  • Geriatric Depression Scale (GDS) [Time frame: change from baseline at 1 week follow up]
  • Neuro evaluation [Time frame: baseline and 1 week follow up]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Kessler Foundation — West Orange

Publications

  • Boukrina O, Yamin A, Yue GH, Kong Y, Koush Y. Feasibility Randomized Controlled Trial of Real-Time fMRI Neurofeedback for Reading Rehabilitation in Aphasia. Stroke. 2026 Jun;57(6):1535-1548. doi: 10.1161/STROKEAHA.125.054877. Epub 2026 Apr 10. PMID 41958417
  • Boukrina O, Yamin A, Yue GH, Kong Y, Koush Y. Feasibility of real-time fMRI neurofeedback for rehabilitation of reading deficits in aphasia. medRxiv [Preprint]. 2025 Jan 5:2025.01.03.25319980. doi: 10.1101/2025.01.03.25319980. PMID 39802782

Identifiers

NCT: NCT04875936 · R-1147-21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗