Neurofeedback Intervention for Reading Deficits in Subacute Stroke

NCT04875936 | Recruiting DMC

• 1 other identifier: R-1147-21
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Dyslexia, Acquired

Outcome Measures

Primary Outcomes (2)

• Reading Aloud Accuracy

  Read aloud 136 words to produce an accuracy score in percent correct.

  change from baseline at intervention week 1, 2, and 3

• fMRI Brain Activity

  Whole-brain and region of interest activation and resting state functional connectivity

  change from baseline at intervention week 1, 2, and 3

Secondary Outcomes (6)

• Reading Comprehension Battery for Aphasia (RCBA-2)

  change from baseline at 1 week follow up

• Western Aphasia Battery-Revised (WAB-R) Bedside

  change from baseline at 1 week follow up

• Boston Naming Test (BNT-short)

  change from baseline at 1 week follow up

• Palm Trees and Pyramids test

  change from baseline at 1 week follow up

• Geriatric Depression Scale (GDS)

  change from baseline at 1 week follow up

Study Arms (2)

Motor Imagery and Contingent Neurofeedback (NFB)

EXPERIMENTAL

This group will receive real-time fMRI NFB on the bases of participant's own brain activity

Behavioral: Motor Imagery and Real-Time fMRI Neurofeedback

Motor Imagery and Non-contingent Neurofeedback (NFB)

SHAM COMPARATOR

This group will receive group will receive fMRI NFB based on another participant's brain activity

Behavioral: Motor Imagery and Sham fMRI Neurofeedback

Interventions

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 Contingent Neurofeedback (NFB)

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.

Motor Imagery and Non-contingent Neurofeedback (NFB)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Stroke; Dyslexia, Acquired

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to the nature of real-time fMRI neurofeedback they will receive: contingent or non-contingent.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Participants are randomly assigned to one of 2 groups

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 6, 2021
• Study Start: April 3, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data may be shared after the acceptance for publication of the main findings of the study.
• Access Criteria: Data may be shared upon request and following the establishment of a data sharing agreement, that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)