Clinical trial NCT03833518: Cortical Biomarkers of Hand Function and Recovery After Injury
Official title: Cortical Biomarkers of Hand Function and Recovery After Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Spinal Cord Injuries
Keywords: hand
rehabilitation
motor cortex
Lead sponsor: VA Pittsburgh Healthcare System
Sponsor class: FED
Collaborators: name: University of Pittsburgh
First posted: 2019-02-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study to collect data to support a VA grant submission to study fMRI and neurophysiological predictors of hand function and recovery during a robotic intervention in people with hand impairments due to stroke or spinal cord injury.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a pilot study to collect data to support a VA grant submission to study fMRI and neurophysiological predictors of hand function and recovery during a robotic intervention in people with hand impairments due to stroke or spinal cord injury.

Detailed description: The loss of arm and hand function after cervical spinal cord injury (SCI) limits independence and increases the cost of care. As a result, Veterans with tetraplegia prioritize restoration of hand and arm function over all other rehabilitation goals. Similar to SCI, stroke of supraspinal areas involved in motor control results in acute movement deficits in more than 85% of survivors. Despite advances in treatment and rehabilitation, 50% of stroke survivors have persistent hand impairment. The loss of hand function and dexterity limits the ability to perform many activities of daily living, and thus limits independence. Since motor deficits are often permanent after SCI and stroke, new strategies are needed to restore dexterous hand function.

Advances in functional imaging have enabled the measurement of finger-related activation patterns in somatosensory cortex, but little is known about how these representational patterns are impacted when hand function is lost. Prior studies of gross movements have reported reorganization of cortical activity after injury. The investigators aim to improve dexterous hand function by increasing our understanding of finger-related cortical reorganization after lesions to the spinal or supraspinal structures. This understanding could allow discrimination between adaptive and maladaptive patterns underlying hand function and guide restorative therapies. Additionally, imaging biomarkers of injury often track with functional recovery.

The aim is to improve dexterous hand function by increasing our understanding of finger-related cortical reorganization after lesions to the spinal or supraspinal structures. This understanding could allow discrimination between adaptive and maladaptive patterns underlying hand function and guide restorative therapies. Additionally, imaging biomarkers of injury often track with functional recovery.

Eligibility criteria: Inclusion Criteria:

* Normal or corrected to normal vision
* Hand impairment due to spinal cord injury or stroke
* Weakness of fingers
* One year after stroke or spinal cord injury
* Some proprioception (can feel when finger is moved, without seeing)
* Minimal spasticity

Exclusion Criteria:

* Implanted metal with is unsafe for MRI
* Pregnant or expecting to become pregnant
* History of hand surgery which is under evaluation
* Cognitive or language issues that would interfere with following directions
* Other neurological disorder that would affect movement
* History of seizure or epilepsy
* Body weight \> 300 pounds

Primary outcomes:
measure: Number of participants that show significant finger-specific activation prior to the intervention
timeFrame: Baseline, prior to intervention, week 1
Secondary outcomes:
measure: Change from baseline finger strength after rehabilitation intervention
timeFrame: After intervention, 12 weeks
measure: Change from baseline in finger dexterity after rehabilitation intervention
timeFrame: After intervention, 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: US Department of Veterans Affairs
name: Jennifer Collinger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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