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| ID | Type | Description | Link |
|---|---|---|---|
| 17SDG33690002 | Other Grant/Funding Number | American Heart Association |
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The primary goal of this project is to establish whether fMRI measurements of brain connectivity measured before and after interaction with a sensorimotor task can predict subsequent training-induced gains in motor function in a population of individuals with chronic stroke.
This study involves individuals with chronic motor impairment resulting from stroke. The procedures include one fMRI session (baseline), followed by twelve training visits (2 or 3 times per week over 4-5 weeks) focused on training motor function of the hand and wrist conducted with a physical therapist. During imaging, participants interact with an MRI-compatible joystick that will cue participants to move their wrist in a controlled way. Before and after the training program, subjects will undergo behavioral testing with a physical therapist to quantify changes in clinical measures of impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Physical Therapy Intervention | Experimental | The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Physical Therapy Intervention | Behavioral | The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from pre-post task changes in resting-state functional connectivity | The primary outcome is the goodness of fit (R^2) of a regression model relating brain connectivity measures (predictors) to gains in motor function after stroke (clinical measurement). Predictors: resting-state functional connectivity measured using resting-state fMRI (rs-fMRI). Connectivity is quantified as Fisher-transformed correlation coefficients (z scores, unitless) of signal measured in pairs of regions (edges) within the cortico-thalamic-cerebellar network. Predictors include baseline (pre-task) connectivity and connectivity changes calculated as the difference between post-task and pre-task rs-fMRI measurements. Clinical measurement: change in Upper Extremity Fugl-Meyer Assessment (FM-UE) score (units: points), calculated as post-intervention FM-UE minus pre-intervention FM-UE. Outcome: model goodness of fit (R^2, unitless). We use a custom LASSO-based variable selection method to construct the final model given multiple predictors and quantify the model fit via R^2. | Brain connectivity is measured during the MRI visit conducted at Baseline. rsFMRI scans are collected within 10 minutes before and after a motor task. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from corticospinal tract injury | The secondary outcome is the goodness of fit (R^2) of a linear regression model relating corticospinal tract injury (predictor) to gains in motor function after stroke (clinical measurement). Predictor: percent corticospinal tract injury (%CST injury) quantified using a structural MRI brain scan (FLAIR). The FLAIR image shows the location and volume of lesioned tissue, and %CST injury is quantified as the percentage of CST axon bundles (derived from a previously published healthy template) that overlap with the lesion (predictor units: percent damaged axon bundles). Clinical measurement: change in Upper Extremity Fugl-Meyer Assessment (FM-UE) score (units: points), calculated as post-intervention FM-UE minus pre-intervention FM-UE. Outcome: model goodness of fit (R^2, unitless). We use linear regression to relate %CST injury to the change in FM-UE and quantify the model's fit via R^2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Biomedical and Brain Imaging | Newark | Delaware | 19713 | United States | ||
| STAR Health Sciences Complex |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Structural brain scan (FLAIR) is acquired once during the MRI visit at Baseline. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period. |
| Newark |
| Delaware |
| 19713 |
| United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |