Cortical Biomarkers of Hand Function and Recovery After Injury

Sponsor
VA Pittsburgh Healthcare System (U.S. Fed)
Overall Status
Terminated
CT.gov ID
NCT03833518
Collaborator
University of Pittsburgh (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation using motorized glove for stroke and spinal cord injury
  • Other: Functional MRI for stroke and spinal cord injury
  • Other: Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Cortical Biomarkers of Hand Function and Recovery After Injury
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Aug 15, 2020
Actual Study Completion Date :
Oct 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hand impairment due to stroke or spinal cord injury

Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.

Other: Rehabilitation using motorized glove for stroke and spinal cord injury
Individuals with hand impairment due to stroke or spinal cord injury will wear a motorized glove (Gloreha Sinfonia), or exoskeleton, as part of a rehabilitation protocol to improve dexterity. For each exercise, participants will attempt to do the action, receiving assistance as necessary via powered motors that can move each finger through its passive range of motion based on the current and target position.
Other Names:
  • Exoskeleton therapy
  • Other: Functional MRI for stroke and spinal cord injury
    All participants will undergo 3 functional MRI's (fMRI's), two at the beginning of the experiment to document brain activity related to movement intention and ability to sense movement. A third MRI will be performed after the rehabilitation is completed to document the change in brain activity related to movement intention and ability to sense movement.
    Other Names:
  • fMRI
  • Other: Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury
    Stimulation of the nervous system may be performed using a magnetic stimulator. TMS of the central nervous system is optional. Whether or not a participant undergoes TMS will depend upon their consent, their eligibility for TMS (i.e. no seizure history), and their neurological response to TMS.
    Other Names:
  • TMS
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants that show significant finger-specific activation prior to the intervention [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 Outcome Measures

    1. Change from baseline finger strength after rehabilitation intervention [After intervention, 12 weeks]

      The investigators will assess finger strength of participants both before and after the rehabilitation intervention. The change in in finger strength will serve as a secondary outcome measure.

    2. Change from baseline in finger dexterity after rehabilitation intervention [After intervention, 12 weeks]

      The investigators will assess each participant's ability to isolate movement of individual fingers both before and after the rehabilitation intervention. The change in this measure of dexterity will serve as a secondary outcome measure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • VA Pittsburgh Healthcare System
    • University of Pittsburgh

    Investigators

    • Principal Investigator: Jennifer Collinger, PhD, US Department of Veterans Affairs

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jennifer Collinger, Research Biomedical Engineer, VA Pittsburgh Healthcare System
    ClinicalTrials.gov Identifier:
    NCT03833518
    Other Study ID Numbers:
    • Pro00002855
    First Posted:
    Feb 7, 2019
    Last Update Posted:
    May 6, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Jennifer Collinger, Research Biomedical Engineer, VA Pittsburgh Healthcare System
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2021