Spinal Plasticity to Enhance Motor Retraining After Stroke

NCT ID: NCT03645122

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2023-12-29

Brief Summary

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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

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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.

Conditions

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Stroke Cerebrovascular Accident Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PCMS REST

PCMS will be triggered while the hand/digits are at rest.

Group Type EXPERIMENTAL

Paired corticospinal-motoneuronal stimulation (PCMS)

Intervention Type 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

SHAM stimulation will be triggered when a criterion level of force stability by the hand/digits is achieved.

Group Type ACTIVE_COMPARATOR

Sham stimulation

Intervention Type 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.

PCMS ACTIVE

PCMS will be triggered when a criterion level of force stability by the hand/digits is achieved.

Group Type EXPERIMENTAL

Paired corticospinal-motoneuronal stimulation (PCMS)

Intervention Type 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.

Interventions

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Paired corticospinal-motoneuronal stimulation (PCMS)

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.

Intervention Type OTHER

Sham stimulation

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael A. Urbin, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22179539 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1617296

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

B2837-W

Identifier Type: -

Identifier Source: org_study_id

NCT03638570

Identifier Type: -

Identifier Source: nct_alias

NCT03639116

Identifier Type: -

Identifier Source: nct_alias

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