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Clinical Trials/NCT04875936
NCT04875936
Recruiting
N/A

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

Kessler Foundation1 site in 1 country28 target enrollmentApril 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Kessler Foundation
Enrollment
28
Locations
1
Primary Endpoint
Reading Aloud Accuracy
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 3, 2023
End Date
June 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Olga Boukrina

Research Scientist

Kessler Foundation

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)

Outcomes

Primary Outcomes

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.

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

  • 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)
  • Neuro evaluation(baseline and 1 week follow up)

Study Sites (1)

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