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The goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.
To establish a link between the physiological mechanisms driving enhanced motor control in response to VNS, subjects will undergo progressive training on a visuomotor task that requires fine gradation of voluntary motor output to control a moving object through target boundaries. In separate groups, VNS or sham stimulation will be paired with movement when a minimal time-on-target (ToT) is achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vagus nerve stimulation (VNS) | Experimental | Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. VNS will be delivered when a minimum level of accuracy has been achieved. |
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| Sham stimulation | Sham Comparator | Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. Sham stimulation will be delivered when a minimum level of accuracy has been achieved. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training | Other | Controlling movement of an object on computer screen by adjusting muscle activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in time-on-target score. | The score reflects the total time the object overlaps any part of targets, expressed as a percentage (0-100) of the total possible time. Thus, a score of 0 is the worst possible score, whereas, 100 is the best possible score. The primary endpoint is the change from baseline (ie, before training) in the time-on-target score. | 3 weeks |
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Inclusion Criteria:
INDIVIDUALS WHO HAVE HAD A STROKE:
Diagnosis of first ever stroke
At least 6 months after stroke onset
Motor-evoked potentials in hand/arm muscles
Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.
ALL INDIVIDUALS:
Between the ages of 18 and 75 years old
Exclusion Criteria:
INDIVIDUALS WHO HAVE HAD A STROKE:
Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators
ALL INDIVIDUALS:
Neurological disorder(s) influencing movement (besides stroke)
History of seizure or epilepsy
Metallic brain implants
Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers
Pregnant or expecting to become pregnant
Difficulty maintaining alertness and/or remaining still
Silicone or plastic allergy
History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)
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| Name | Affiliation | Role |
|---|---|---|
| George F Wittenberg, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8172497 | Background | Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9. | |
| 22341029 | Background | Pollock A, St George B, Fenton M, Firkins L. Top ten research priorities relating to life after stroke. Lancet Neurol. 2012 Mar;11(3):209. doi: 10.1016/S1474-4422(12)70029-7. No abstract available. |
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The research team may share data with scientists at other centers for the purpose of data analysis and collaboration. Research information and data may be shared with investigators conducting other research. This information will not be identifiable.
Information may be shared while data is being recorded, analyzed, and/or prior to publication. Data may be available for seven years after manuscripts are published.
Data use agreements will be established with scientists at other centers, or conducting other research, prior to any data sharing.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Vagus Nerve Stimulation | Other | Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity. |
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| Sham Stimulation | Other | Sub-threshold stimulation that does not activate neural structures. |
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| 19608100 | Background | Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4. |
| 21262990 | Background | Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24. |
| 22079923 | Background | Porter BA, Khodaparast N, Fayyaz T, Cheung RJ, Ahmed SS, Vrana WA, Rennaker RL 2nd, Kilgard MP. Repeatedly pairing vagus nerve stimulation with a movement reorganizes primary motor cortex. Cereb Cortex. 2012 Oct;22(10):2365-74. doi: 10.1093/cercor/bhr316. Epub 2011 Nov 10. |
| 23954448 | Background | Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15. |
| 24553102 | Background | Khodaparast N, Hays SA, Sloan AM, Fayyaz T, Hulsey DR, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation delivered during motor rehabilitation improves recovery in a rat model of stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):698-706. doi: 10.1177/1545968314521006. Epub 2014 Feb 18. |
| 29371435 | Background | Meyers EC, Solorzano BR, James J, Ganzer PD, Lai ES, Rennaker RL 2nd, Kilgard MP, Hays SA. Vagus Nerve Stimulation Enhances Stable Plasticity and Generalization of Stroke Recovery. Stroke. 2018 Mar;49(3):710-717. doi: 10.1161/STROKEAHA.117.019202. Epub 2018 Jan 25. |
| 26645257 | Background | Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8. |
| 29562561 | Background | Kilgard MP, Rennaker RL, Alexander J, Dawson J. Vagus nerve stimulation paired with tactile training improved sensory function in a chronic stroke patient. NeuroRehabilitation. 2018;42(2):159-165. doi: 10.3233/NRE-172273. |
| 30355189 | Background | Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |