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Neurofeedback Intervention for Reading Deficits in Subacute Stroke (ReadingNFB)

Primary Purpose

Stroke, Dyslexia, Acquired

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motor Imagery and Real-Time fMRI Neurofeedback
Motor Imagery and Sham fMRI Neurofeedback
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Motor Imagery and Contingent Neurofeedback (NFB)

Motor Imagery and Non-contingent Neurofeedback (NFB)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reading Aloud Accuracy
Read aloud 136 words to produce an accuracy score in percent correct.
fMRI Brain Activity
Whole-brain and region of interest activation and resting state functional connectivity

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 29, 2021
Last Updated
May 1, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04875936
Brief Title
Neurofeedback Intervention for Reading Deficits in Subacute Stroke
Acronym
ReadingNFB
Official Title
Rehabilitation of Reading Deficits in Subacute Stroke Using Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dyslexia, Acquired

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of 2 groups
Masking
Participant
Masking Description
Participants will be masked to the nature of real-time fMRI neurofeedback they will receive: contingent or non-contingent.
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor Imagery and Contingent Neurofeedback (NFB)
Arm Type
Experimental
Arm Description
This group will receive real-time fMRI NFB on the bases of participant's own brain activity
Arm Title
Motor Imagery and Non-contingent Neurofeedback (NFB)
Arm Type
Sham Comparator
Arm Description
This group will receive group will receive fMRI NFB based on another participant's brain activity
Intervention Type
Behavioral
Intervention Name(s)
Motor Imagery and Real-Time fMRI Neurofeedback
Intervention Description
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
Intervention Name(s)
Motor Imagery and Sham fMRI Neurofeedback
Intervention Description
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 Information:
Title
Reading Aloud Accuracy
Description
Read aloud 136 words to produce an accuracy score in percent correct.
Time Frame
change from baseline at intervention week 1, 2, and 3
Title
fMRI Brain Activity
Description
Whole-brain and region of interest activation and resting state functional connectivity
Time Frame
change from baseline at intervention week 1, 2, and 3
Secondary Outcome Measure Information:
Title
Reading Comprehension Battery for Aphasia (RCBA-2)
Description
Letter, word, sentence, paragraph and text-level reading comprehension test designed for aphasia. Score range 0-100, higher scores correspond to better reading ability.
Time Frame
change from baseline at 1 week follow up
Title
Western Aphasia Battery-Revised (WAB-R) Bedside
Description
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.
Time Frame
change from baseline at 1 week follow up
Title
Boston Naming Test (BNT-short)
Description
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.
Time Frame
change from baseline at 1 week follow up
Title
Palm Trees and Pyramids test
Description
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.
Time Frame
change from baseline at 1 week follow up
Title
Geriatric Depression Scale (GDS)
Description
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.
Time Frame
change from baseline at 1 week follow up
Title
Neuro evaluation
Description
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.
Time Frame
baseline and 1 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Boukrina, Ph.D.
Phone
973-324-3587
Email
oboukrina@kesslerfoundation.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data generated in this project may be shared in accordance with the funding agency (NIH) and site organization (Kessler Foundation) policies, as well as the Notice of Privacy of Practices and Informed Consent documents signed by each participant in the study. In case data are shared, they will be de-identified, such that no link can be made to the individual participant. To prevent the possibility of deductive disclosure of participants through brain scans and the association with the rehabilitation hospital, data and associated documentation will be made available to users only under a data-sharing agreement.
IPD Sharing Time Frame
Data may be shared after the acceptance for publication of the main findings of the study.
IPD Sharing Access Criteria
Data may be shared upon request and following the establishment of a data sharing agreement, that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Learn more about this trial

Neurofeedback Intervention for Reading Deficits in Subacute Stroke

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