Spinal Plasticity to Enhance Motor Retraining After Stroke

Not Applicable

Completed

• Conditions: Stroke; Hemiparesis; Cerebrovascular Accident
• Interventions: Other: Paired corticospinal-motoneuronal stimulation (PCMS); Other: Sham stimulation

• Registration Number: NCT03645122
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Study Start: 2019-02-04
• Primary Completion: 2023-09-29
• Study Completion: 2023-12-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCMS REST	Paired corticospinal-motoneuronal stimulation (PCMS)	PCMS will be triggered while the hand/digits are at rest.
SHAM	Sham stimulation	SHAM stimulation will be triggered when a criterion level of force stability by the hand/digits is achieved.
PCMS ACTIVE	Paired corticospinal-motoneuronal stimulation (PCMS)	PCMS will be triggered when a criterion level of force stability by the hand/digits is achieved.

Primary Outcome Measures

Name	Time	Method
Motor Control & Learning	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.

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States