Neurofeedback Intervention for Reading Deficits in Subacute Stroke

NCT ID: NCT04875936

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2026-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Motor Imagery and Contingent Neurofeedback (NFB)

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

Group Type: EXPERIMENTAL

Motor Imagery and Real-Time fMRI Neurofeedback

Intervention Type: 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 Non-contingent Neurofeedback (NFB)

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

Group Type: SHAM_COMPARATOR

Motor Imagery and Sham fMRI Neurofeedback

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Olga Boukrina

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Olga Boukrina, Ph.D.

Role: primary

oboukrina@kesslerfoundation.org

9733243587

References

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.

Reference Type: DERIVED

PMID: 39802782 (View on PubMed)

Other Identifiers

R-1147-21

Identifier Type: -

Identifier Source: org_study_id