Left-Hemisphere Stroke Clinical Trial
Official title:
Brain Markers Predicting Reading Recovery After Stroke
NCT number | NCT03845686 |
Other study ID # | R-784-13 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 4, 2018 |
Est. completion date | July 1, 2021 |
Verified date | April 2021 |
Source | Kessler Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | July 1, 2021 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation | National Center for Medical Rehabilitation Research (NCMRR), Rutgers University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reading Aloud Accuracy - subacute | Percent correct of single words read aloud | within 1 week of study enrollment | |
Primary | Reading Aloud Accuracy - chronic | Percent correct of single words read aloud | 3 months after study enrollment | |
Primary | Phonology Task Accuracy - subacute | 2-alternative forced choice task of pseudoword rhyming | within 1 week of enrollment | |
Primary | Phonology Task Accuracy - chronic | 2-alternative forced choice task of pseudoword rhyming | 3 months after study enrollment | |
Primary | Semantics Task Accuracy - subacute | 2-alternative forced choice task of picture matching | within 1 week of enrollment | |
Primary | Semantics Task Accuracy - chronic | 2-alternative forced choice task of picture matching | 3 months after study enrollment | |
Primary | Orthography Task Accuracy - subacute | 2 alternative forced choice between a correctly spelled word and a phonological foil | within 1 week of enrollment | |
Primary | Orthography Task Accuracy - chronic | 2 alternative forced choice between a correctly spelled word and a phonological foil | 3 months after study enrollment | |
Primary | Perfusion MRI - subacute | Subacute cerebral blood flow (CBF) in peri-infarct tissue, left reading network, and right homologous areas | within 1 week of enrollment | |
Primary | Perfusion MRI - chronic | Subacute-to-chronic change of CBF in peri-infarct tissue, left reading network, and right homologous areas | 3 months after enrollment | |
Primary | Functional MRI - subacute | Brain activation for reading words and nonwords; task-induced change in oxygen consumption | within 1 week of enrollment | |
Primary | 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 |