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Completed

NCT Number: NCT03645122

Spinal Plasticity to Enhance Motor Retraining After Stroke

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paired corticospinal-motoneuronal stimulation (PCMS)

Other

Synapses in the spinal cord that transmit voluntary movement commands from the brain to hand muscles will be activated by noninvasive stimulation in a particular sequence and interval that has been shown to strengthen connectivity.

Sham stimulation

Other

Synapses in the spinal cord that transmit voluntary movement commands from the brain to hand muscles will not be activated by noninvasive stimulation in a particular sequence and interval that has been shown to strengthen connectivity.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Plasticity in the Spinal Cord to Enhance Motor Retraining After Stroke

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.