ReadingNFB: Neurofeedback Intervention for Reading Deficits in Subacute Stroke

Sponsor
Kessler Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04875936
Collaborator
(none)
28
1
2
46.9
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motor Imagery and Real-Time fMRI Neurofeedback
  • Behavioral: Motor Imagery and Sham fMRI Neurofeedback
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to one of 2 groupsParticipants are randomly assigned to one of 2 groups
Masking:
Single (Participant)
Masking Description:
Participants will be masked to the nature of real-time fMRI neurofeedback they will receive: contingent or non-contingent.
Primary Purpose:
Treatment
Official Title:
Rehabilitation of Reading Deficits in Subacute Stroke Using Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2026
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

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 (<5 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 (<5 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.

Outcome Measures

Primary Outcome Measures

  1. Reading Aloud Accuracy [change from baseline at intervention week 1, 2, and 3]

    Read aloud 136 words to produce an accuracy score in percent correct.

  2. fMRI Brain Activity [change from baseline at intervention week 1, 2, and 3]

    Whole-brain and region of interest activation and resting state functional connectivity

Secondary Outcome Measures

  1. Reading Comprehension Battery for Aphasia (RCBA-2) [change from baseline at 1 week follow up]

    Letter, word, sentence, paragraph and text-level reading comprehension test designed for aphasia. Score range 0-100, higher scores correspond to better reading ability.

  2. Western Aphasia Battery-Revised (WAB-R) Bedside [change from baseline at 1 week follow up]

    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.

  3. Boston Naming Test (BNT-short) [change from baseline at 1 week follow up]

    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.

  4. Palm Trees and Pyramids test [change from baseline at 1 week follow up]

    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.

  5. Geriatric Depression Scale (GDS) [change from baseline at 1 week follow up]

    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.

  6. Neuro evaluation [baseline and 1 week follow up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • First-ever left-hemisphere stroke < 5 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kessler Foundation West Orange New Jersey United States 07052

Sponsors and Collaborators

  • Kessler Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olga Boukrina, Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT04875936
Other Study ID Numbers:
  • R-1147-21
First Posted:
May 6, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022