Spinal Plasticity to Enhance Motor Retraining After Stroke
NCT ID: NCT03645122
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2019-02-04
2023-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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PCMS REST
PCMS will be triggered while the hand/digits are at rest.
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.
SHAM
SHAM stimulation will be triggered when a criterion level of force stability by the hand/digits is achieved.
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.
PCMS ACTIVE
PCMS will be triggered when a criterion level of force stability by the hand/digits is achieved.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of first-ever stroke
* Stroke onset of at least six months prior to the time of participation
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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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
Countries
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
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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