Cortical Biomarkers of Hand Function and Recovery After Injury

Not Applicable

Terminated

• Conditions: Stroke; Spinal Cord Injuries
• Interventions: 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

• Registration Number: NCT03833518
• Lead Sponsor: VA Pittsburgh Healthcare System

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.

Study Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-07
• Study Start: 2019-09-01
• Primary Completion: 2020-08-15
• Study Completion: 2020-10-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hand impairment due to stroke or spinal cord injury	Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury	Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.
Hand impairment due to stroke or spinal cord injury	Functional MRI for stroke and spinal cord injury	Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.
Hand impairment due to stroke or spinal cord injury	Rehabilitation using motorized glove for stroke and spinal cord injury	Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States