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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS114046-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The goal of this study is to determine which parts of the brain make it possible for some people to move skillfully with their left non-dominant hand.
This is a one-visit study, in which right-handed participants (individuals with unilateral peripheral nerve injury to the right upper limb, and healthy controls) will complete surveys and perform movement tasks. Movement tasks will be performed inside and outside a magnetic resonance imaging (MRI) scanner.
Some participants will also receive transcranial magnetic stimulation (TMS) to briefly interfere with these putative brain networks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Movement task | Experimental | All participants perform the STEGA-MRI (standardized tracing evaluation & grapheme assessment - MRI) precision drawing task during fMRI scanning. Motor assessments outside the MRI do not qualify as interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STEGA-MRI | Other | Precision drawing task (movement assessment) |
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| Measure | Description | Time Frame |
|---|---|---|
| BOLD (blood oxygen level dependent) signal in ROIs (regions of interest) | BOLD signal in key ROIs (primary motor and posterior parietal cortex). ROI selection may be revisited after preliminary data review (35 participants) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Drawing smoothness | Velocity smoothness in STEGA-MRI (Standardized Tracing Evaluation and Grapheme Assessment - MRI version) task | Day 1 |
| Hand choice | Percentage of grasps made with right hand |
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This study contains two groups: typical controls and patients. Participants will be matched by age and sex between the two groups. No randomization will occur.
A. Inclusion criteria (all participants):
B. Inclusion criteria (patients only):
Chronic unilateral upper extremity peripheral nerve injury to the right side
Some impairment to writing, requiring both of:
C. Exclusion criteria (all participants)
Currently intoxicated or otherwise non-compliant
Chronic pain diagnosis unrelated to the nerve injury
Uncorrected visual impairment that interferes with ability to see drawings in MRI
Motor function diagnoses that affect function of the left hand, now or in past 2 years
Motor function diagnoses currently affecting the right hand, unrelated to the nerve injury
Upper extremity surgery, including peripheral nerve surgery, within last 2 months
Contraindication for MRI
Contraindication for transcranial magnetic stimulation (TMS)
Amputation affecting any part of thumb, index, or middle fingers (including higher level, e.g. whole hand)
History of chronic cocaine use (based on medical record or volunteered; will not actively inquire)
Diagnosis of schizophrenia or other rare psychiatric disorder
History of major neurological diagnosis, e.g. stroke, traumatic brain injury, Alzheimer's, Parkinson's
D. Exclusion criteria (controls only)
1. Motor function diagnoses that affect function of either hand, now or in past 2 years
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin A Philip, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
For participants who consent to us sharing their data with other researchers, we will share all anonymized data (behavioral, survey, and MRI), including data dictionaries.
Note that this clinical trial is a "prospective basic science study involving human participants;" i.e., a study that falls within the NIH definition of clinical trial while also meeting the definition of basic research.
Will become available after summary data are published. Will remain available indefinitely.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2024 | Apr 24, 2024 | ICF_001.pdf |
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The only "intervention" is the movement task. All participants receive the same task.
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During TMS, participants will be masked to whether they receive effective or sham stimulation on a given trial.
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| Day 1 |