Brain Markers Predicting Reading Recovery After Stroke
1 other identifier
observational
26
1 country
1
Brief Summary
For millions of stroke survivors acquired reading deficits represent a significant handicap preventing them from returning to work or continuing their education. The goal of the proposed research is to investigate what brain mechanisms enable recovery of impaired reading. To achieve this goal, the project will directly measure changes in brain perfusion (blood flow) and activation among recovering stroke survivors using a neuroimaging technique called perfusion fMRI (functional Magnetic Resonance Imaging). The project will test if re-perfusion (return of circulation) and re-appearance of reading-related brain activity in the left-brain network for reading is associated with recovery. The ability to predict recovery from neuroimaging has tremendous value in rehabilitation for generating prognoses. It may also dramatically improve the quality of research evaluation for novel, targeted interventions such as noninvasive brain stimulation or pharmacologic therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2018
CompletedFirst Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedAugust 31, 2021
April 1, 2021
3.2 years
February 15, 2019
August 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Reading Aloud Accuracy - subacute
Percent correct of single words read aloud
within 1 week of study enrollment
Reading Aloud Accuracy - chronic
Percent correct of single words read aloud
3 months after study enrollment
Phonology Task Accuracy - subacute
2-alternative forced choice task of pseudoword rhyming
within 1 week of enrollment
Phonology Task Accuracy - chronic
2-alternative forced choice task of pseudoword rhyming
3 months after study enrollment
Semantics Task Accuracy - subacute
2-alternative forced choice task of picture matching
within 1 week of enrollment
Semantics Task Accuracy - chronic
2-alternative forced choice task of picture matching
3 months after study enrollment
Orthography Task Accuracy - subacute
2 alternative forced choice between a correctly spelled word and a phonological foil
within 1 week of enrollment
Orthography Task Accuracy - chronic
2 alternative forced choice between a correctly spelled word and a phonological foil
3 months after study enrollment
Perfusion MRI - subacute
Subacute cerebral blood flow (CBF) in peri-infarct tissue, left reading network, and right homologous areas
within 1 week of enrollment
Perfusion MRI - chronic
Subacute-to-chronic change of CBF in peri-infarct tissue, left reading network, and right homologous areas
3 months after enrollment
Functional MRI - subacute
Brain activation for reading words and nonwords; task-induced change in oxygen consumption
within 1 week of enrollment
Functional MRI - chronic
Subacute-to-chronic change of brain activation for reading words and pseudowords; longitudinal and task-induced change in oxygen consumption
3 months after enrollment
Study Arms (2)
Subacute Stroke Sample
Participants with first-ever left-brain stroke, \< 4 weeks post stroke, age \>18 years, right-handed, fluent and literate in English prior to stroke, no prior neurological disorders or clinical stroke event, \<4 weeks post-stroke; able to undergo an MRI and complete study tasks, and presence of reading deficits.
Chronic Stroke Sample
The same group of participants examined in the chronic post-stroke period (\>3 months post-stroke)
Interventions
The goal of this test is to measure brain activity during subacute and chronic post-stroke period using a widely available non-invasive neuroimaging tool - functional Magnetic Resonance Imaging (fMRI). Because fMRI relies in part on cerebral blood flow, which is altered in stroke, measuring longitudinal changes in neural activity with fMRI requires that we control for concomitant changes in blood circulation. To do this, we will employ a novel dual-echo perfusion fMRI sequence, which will allow us to separately estimate neural and vascular contributions to fMRI.
Eligibility Criteria
34 participants with first-ever left-brain stroke
You may qualify if:
- age \>18 years
- right-handed
- fluent and literate in English prior to stroke
- no prior neurological disorders or clinical stroke event
- \<4 weeks post-stroke
- ability to undergo an MRI and complete study tasks
- presence of reading deficits
You may not qualify if:
- participants with severe aphasia resulting in severe language deficits and inability to consent
- participants with very large lesions resulting in severe cognitive deficits and inability to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kessler Foundationlead
- Rutgers Universitycollaborator
- National Center for Medical Rehabilitation Research (NCMRR)collaborator
Study Sites (1)
Kessler Foundation
West Orange, New Jersey, 07052, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 19, 2019
Study Start
April 4, 2018
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
August 31, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The data will be available 1 year after study completion (3/31/2021 - anticipated). The data will be available indefinitely
- Access Criteria
- The data will be made available upon request
Data generated in this project may be shared in accordance with the NIH and Kessler Foundation policies, as well as the Notice of Privacy of Practices signed by each participant in the study. In case data is shared, it will be de-identified, such that no link can be made to the individual participant. Data may be shared upon request after the acceptance for publication of the main findings of the study. Publication of findings will occur during the project, if appropriate, or at the conclusion of the project, consistently with the typical scientific process. Access to methodology and software tools generated in the course of the project will be granted for educational, research, and non-profit purposes. Sharing of such study resources will be provided via web-based applications (e.g., GitHub), as appropriate.