Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spinal Plasticity to Enhance Motor Retraining After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645122
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Stroke Cerebrovascular Accident Hemiparesis Procedure: Noninvasive neuromodulation via paired corticospinal-motoneuronal stimulation (PCMS) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Transcranial magnetic stimulation targeting the region of the brain responsible for voluntary movement control and electrical stimulation to a peripheral nerve innervating hand muscles will be triggered at an interval that elicits action potentials arriving in a set sequence and predetermined delay in the spinal cord.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Plasticity in the Spinal Cord to Enhance Motor Retraining After Stroke
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Procedure: Noninvasive neuromodulation via paired corticospinal-motoneuronal stimulation (PCMS)
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.
 Procedure: Noninvasive neuromodulation via paired corticospinal-motoneuronal stimulation (PCMS)
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645122


Contacts
Layout table for location contacts
Contact: Nicholas J Gatto, BS (412) 822-3664 nicholas.gatto@va.gov
Contact: Michael A Urbin, PhD (412) 688-6000 Michael.Urbin@va.gov

Locations
Layout table for location information
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Nicholas J Gatto, BS    412-822-3664    nicholas.gatto@va.gov   
Principal Investigator: Michael A. Urbin, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Michael A. Urbin, PhD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03645122    
Obsolete Identifiers: NCT03638570, NCT03639116
Other Study ID Numbers: B2837-W
1617296 ( Other Grant/Funding Number: Veterans Health Administration )
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
Neuromodulation
Transcranial magnetic stimulation (TMS)
Electrical stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations