Neurofeedback Intervention for Reading Deficits in Subacute Stroke (ReadingNFB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Dyslexia, Acquired
• Intervention / Treatment: Behavioral: Motor Imagery and Real-Time fMRI Neurofeedback; Behavioral: Motor Imagery and Sham fMRI Neurofeedback

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Olga Boukrina, Ph.D.; Phone Number: 973-324-3587; Email: oboukrina@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• First-ever left-hemisphere stroke < 10 weeks 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motor Imagery and Contingent Neurofeedback (NFB); 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; 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.
Sham Comparator: Motor Imagery and Non-contingent Neurofeedback (NFB); This group will receive group will receive fMRI NFB based on another participant's brain activity	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 practice the same task for 30 min a day as homework.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 1 week follow up
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.	change from baseline at 1 week follow up
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.	change from baseline at 1 week follow up
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.	change from baseline at 1 week follow up
Geriatric Depression Scale (GDS)	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.	change from baseline at 1 week follow up
Neuro evaluation	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.	baseline and 1 week follow up

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Anticipated): June 30, 2026
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Stroke; Dyslexia; Dyslexia, Acquired
• Other Study ID Numbers: R-1147-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data generated in this project may be shared in accordance with the funding agency (NIH) and site organization (Kessler Foundation) policies, as well as the Notice of Privacy of Practices and Informed Consent documents signed by each participant in the study. In case data are shared, they will be de-identified, such that no link can be made to the individual participant. To prevent the possibility of deductive disclosure of participants through brain scans and the association with the rehabilitation hospital, data and associated documentation will be made available to users only under a data-sharing agreement.
• IPD Sharing Time Frame: Data may be shared after the acceptance for publication of the main findings of the study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No