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Clinical Trials/NCT03645122
NCT03645122
Completed
N/A

Plasticity in the Spinal Cord to Enhance Motor Retraining After Stroke

VA Office of Research and Development1 site in 1 country66 target enrollmentFebruary 4, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
VA Office of Research and Development
Enrollment
66
Locations
1
Primary Endpoint
Motor Control & Learning
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The objective of this project is to study the effects of an emerging noninvasive neuromodulation strategy in human stroke survivors with movement-related disability. Muscle weakness after stroke results from the abnormal interaction between cells in the brain that send commands to control movement and cells in the spinal cord that cause muscles to produce movement. The neuromodulation strategy central to this project has been shown the strengthen the physical connection between both cells, producing a change in movement potential of muscles weakened by stroke.

Detailed Description

Stroke is a leading cause of serious long-term disability in the United States with 795,000 individuals suffering a new or recurrent stroke each year. In most cases, disability is associated with incomplete motor recovery of the paretic limb. Full recovery is often not achieved, creating a need for neuromodulation strategies that target the physiological mechanisms impaired by stroke to fully harness the adaptive capacity of the nervous system. The neuromodulation protocol that will be tested in these experiments will target connections between the brain and spinal cord with noninvasive stimulation to enhance movement potential of the hand. Individuals who experienced a single stroke at least 6 months ago may be eligible to participate.

Registry
clinicaltrials.gov
Start Date
February 4, 2019
End Date
December 29, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Between the ages of 18 and 75 years old
  • Diagnosis of first-ever stroke
  • Stroke onset of at least six months prior to the time of participation

Exclusion Criteria

  • History of seizure or epilepsy
  • Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for subjects undergoing MRI)
  • Pregnant or expecting to become pregnant
  • Difficulty maintaining alertness and/or remaining still
  • Body weight \> 300 lbs due to MRI scanner dimensions (for subjects undergoing MRI)
  • Cognitive or language impairments that would interfere with the ability to follow simple instructions, as judged by the investigators
  • Diagnosis of movement disorder(s) other than stroke

Outcomes

Primary Outcomes

Motor Control & Learning

Time Frame: Measured under each condition, with approximately 2 months required for completion of all conditions.

A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed.

Study Sites (1)

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