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Spinal Plasticity to Enhance Motor Retraining After Stroke

Primary Purpose

Stroke, Cerebrovascular Accident, Hemiparesis

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Noninvasive neuromodulation via paired corticospinal-motoneuronal stimulation (PCMS)

About this trial

This is an interventional basic science trial for Stroke focused on measuring Neuromodulation, Transcranial magnetic stimulation (TMS), Electrical stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Physiology

Behavior

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Physiology

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03645122

First Posted

August 22, 2018

Last Updated

October 12, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT03645122

Brief Title

Spinal Plasticity to Enhance Motor Retraining After Stroke

Official Title

Plasticity in the Spinal Cord to Enhance Motor Retraining After Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 4, 2019 (Actual)

Primary Completion Date

September 29, 2023 (Actual)

Study Completion Date

December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Cerebrovascular Accident, Hemiparesis

Keywords

Neuromodulation, Transcranial magnetic stimulation (TMS), Electrical stimulation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physiology

Arm Type

Experimental

Arm Description

Arm Title

Behavior

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Noninvasive neuromodulation via paired corticospinal-motoneuronal stimulation (PCMS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Physiology

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Behavior

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A. Urbin, PhD

Organizational Affiliation

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15240

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22179539

Citation

Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.

Results Reference

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