Neurofeedback Intervention for Reading Deficits in Subacute Stroke

Stroke Clinical Trial

— ReadingNFB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04875936
• Other study ID #: R-1147-21
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyslexia
• Dyslexia, Acquired
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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