- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645122
Spinal Plasticity to Enhance Motor Retraining After Stroke
January 10, 2024 updated by: VA Office of Research and Development
Plasticity in the Spinal Cord 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
66
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 Contact
- Name: Michael A Urbin, PhD
- Phone Number: (412) 688-6000
- Email: Michael.Urbin@va.gov
Study Contact Backup
- Name: Nicholas J Gatto, BS
- Phone Number: (412) 822-3664
- Email: nicholas.gatto@va.gov
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physiology
Different neural elements will be stimulated and evoked potentials will be recorded via electromyography.
Metrics used to quantify evoked potentials will be used to infer changes in physiological functioning of the nervous system.
|
This study is a novel approach to studying neuroplasticity after stroke.
Previous work in humans with incomplete spinal cord injury demonstrates that the resulting plasticity transiently enhances motor output, indicating that there is also therapeutic potential.
This study will attempt to induce bi-directional plasticity in corticospinal-motoneuronal synapses serving an intrinsic hand muscle of the hemiparetic limb.
Control experiments will be completed to provide evidence of the neurophysiological mechanism(s) mediating the effect and to examine behavioral effects.
|
Experimental: Behavior
A visuomotor task will be performed and force signals will be recorded.
Metrics used to quantify force signals will be used to infer changes in control processes governing movement.
|
This study is a novel approach to studying neuroplasticity after stroke.
Previous work in humans with incomplete spinal cord injury demonstrates that the resulting plasticity transiently enhances motor output, indicating that there is also therapeutic potential.
This study will attempt to induce bi-directional plasticity in corticospinal-motoneuronal synapses serving an intrinsic hand muscle of the hemiparetic limb.
Control experiments will be completed to provide evidence of the neurophysiological mechanism(s) mediating the effect and to examine behavioral effects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiology
Time Frame: 12 months
|
Different neural elements will be stimulated and evoked potentials will be recorded via electromyography.
Metrics used to quantify evoked potentials will be used to infer changes in physiological functioning of the nervous system.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior
Time Frame: 12 months
|
A visuomotor task will be performed and force signals will be recorded.
Metrics used to quantify force signals will be used to infer changes in control processes governing movement.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael A. Urbin, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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.
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)
February 4, 2019
Primary Completion (Actual)
September 29, 2023
Study Completion (Actual)
December 29, 2023
Study Registration Dates
First Submitted
August 22, 2018
First Submitted That Met QC Criteria
August 22, 2018
First Posted (Actual)
August 24, 2018
Study Record Updates
Last Update Posted (Actual)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2837-W
- 1617296 (Other Grant/Funding Number: Veterans Health Administration)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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