| ID | Type | Description | Link |
|---|---|---|---|
| 1617296 | Other Grant/Funding Number | Veterans Health Administration |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCMS REST | Experimental | PCMS will be triggered while the hand/digits are at rest. |
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| SHAM | Active Comparator | SHAM stimulation will be triggered when a criterion level of force stability by the hand/digits is achieved. |
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| PCMS ACTIVE | Experimental | PCMS will be triggered when a criterion level of force stability by the hand/digits is achieved. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paired corticospinal-motoneuronal stimulation (PCMS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Control & Learning | A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed. | Measured under each condition, with approximately 2 months required for completion of all conditions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A. Urbin, PhD | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22179539 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PCMS Rest, Sham, PCMS Active | Participants completed 3 conditions in the following randomized order: PCMS Rest, Sham, PCMS Active |
| FG001 | Sham, PCMS Rest, PCMS Active | Participants completed 3 conditions in the following randomized order: Sham, PCMS Rest, PCMS Active |
| FG002 | PCMS Active, Sham, PCMS Rest | Participants completed 3 conditions in the following randomized order: PCMS Active, Sham, PCMS Rest. |
| FG003 | Sham, PCMS Active, PCMS Rest | Participants completed 3 conditions in the following randomized order: Sham, PCMS Active, PCMS Rest |
| FG004 | PCMS Rest, PCMS Active, Sham | Participants completed 3 conditions in the following randomized order: PCMS Rest, PCMS Active, Sham. |
| FG005 | PCMS Active, PCMS Rest, Sham | Participants completed 3 conditions in the following randomized order: PCMS Active, PCMS Rest, Sham. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Condition |
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Motor Control & Learning | A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed. | Posted | Mean | Standard Error | Newton | Measured under each condition, with approximately 2 months required for completion of all conditions. |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rest PCMS | PCMS was administered with the targeted hand muscles at rest. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Director for Clinical and Regulatory Affairs | VA Pittsburgh Healthcare System | 412-822-3669 | Nikitha.Deepak@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2024 | Aug 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2023 | Aug 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Sham stimulation | 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. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | Active PCMS | PCMS administered when subjects achieved a criterion level of force stability during task repetition. |
|
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| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Sham PCMS | Peripheral nerve stimulation was administered and the stimulating coil discharged when subjects achieved a criterion level of force stability during task repetition. The stimulating coil was rotated to prevent activation of the brain, thus, preventing PCMS. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Active PCMS | PCMS was administered when subjects achieved a criterion level of force stability during task repetition. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |