Recruiting

Neurofeedback

Sponsor:

Kessler Foundation

Code:

NCT04875936

Conditions

Stroke

Dyslexia, Acquired

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Motor Imagery and Real-Time fMRI Neurofeedback

Motor Imagery and Sham fMRI Neurofeedback

Study Details

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

Study ID

NCT04875936

Start date

Apr 3, 2023

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Motor Imagery and Contingent Neurofeedback (NFB)

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

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

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Olga Boukrina, Ph.D.

9733243587oboukrina@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-05-08.