Clinical Trials Directory

Trials / Terminated

TerminatedNCT03833518

Cortical Biomarkers of Hand Function and Recovery After Injury

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
VA Pittsburgh Healthcare System · Federal
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERRehabilitation using motorized glove for stroke and spinal cord injuryIndividuals 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.
OTHERFunctional MRI for stroke and spinal cord injuryAll 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.
OTHERTranscranial magnetic stimulation (TMS) for stroke and spinal cord injuryStimulation 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.

Timeline

Start date
2019-09-01
Primary completion
2020-08-15
Completion
2020-10-15
First posted
2019-02-07
Last updated
2021-05-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03833518. Inclusion in this directory is not an endorsement.