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Clinical Trials/NCT03833518
NCT03833518
Terminated
N/A

Cortical Biomarkers of Hand Function and Recovery After Injury

VA Pittsburgh Healthcare System1 site in 1 country1 target enrollmentSeptember 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
VA Pittsburgh Healthcare System
Enrollment
1
Locations
1
Primary Endpoint
Number of participants that show significant finger-specific activation prior to the intervention
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
October 15, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Collinger

Research Biomedical Engineer

VA Pittsburgh Healthcare System

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

Outcomes

Primary Outcomes

Number of participants that show significant finger-specific activation prior to the intervention

Time Frame: Baseline, prior to intervention, week 1

The investigators will use functional magnetic resonance imaging (fMRI) to measure cortical activity relating to finger-specific brain activation before the rehabilitation intervention.

Secondary Outcomes

  • Change from baseline finger strength after rehabilitation intervention(After intervention, 12 weeks)
  • Change from baseline in finger dexterity after rehabilitation intervention(After intervention, 12 weeks)

Study Sites (1)

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