Cortical Biomarkers of Hand Function and Recovery After Injury

April 30, 2021 updated by: Jennifer Collinger, VA Pittsburgh Healthcare System
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, prior to intervention, week 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline finger strength after rehabilitation intervention
Time Frame: 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.
After intervention, 12 weeks
Change from baseline in finger dexterity after rehabilitation intervention
Time Frame: 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.
After intervention, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Pittsburgh Healthcare System

Collaborators

University of Pittsburgh

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

August 15, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (Actual)

February 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00002855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Research information will not be shared with anyone outside of the research team.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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