Stroke Clinical Trial
Official title:
Spinal Plasticity to Reduce Hand Impairment After Stroke
The purpose of the study is to induce plasticity in corticospinal-motoneuronal synapses serving an intrinsic hand muscle of the hemiparetic limb in humans with stroke. Neurologically-intact controls are included to verify that an effect was present in absence of stroke. Outcome measures in controls also provide a reference point that help us to understand the size of the effect and mechanisms mediating the effect in the neurologically-intact system.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | October 2022 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
INCLUSION CRITERIA Individuals who have had a stroke: 1. Diagnosis of first ever subcortical stroke 2. At least 6 months after stroke onset 3. Score of 1 or greater on MRC Scale for the FDI muscle 4. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators. All individuals: 5. Between the ages of 18 and 75 years old 6. U. S. Veterans EXCLUSION CRITERIA Individuals who have had a stroke: 1. 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 2. Diagnosis of neurological disorder(s) other than stroke influence movement All individuals: 3. History of seizure or epilepsy 4. Metallic brain implants 5. Implantable cardioverter defibrillators, insulin pumps, or ventriculoperitoneal shunts 6. Pregnant or expecting to become pregnant 7. Difficulty maintaining alertness and/or remaining still. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Pittsburgh | US Department of Veterans Affairs |
Bunday KL, Perez MA. Motor recovery after spinal cord injury enhanced by strengthening corticospinal synaptic transmission. Curr Biol. 2012 Dec 18;22(24):2355-61. doi: 10.1016/j.cub.2012.10.046. Epub 2012 Nov 29. Erratum in: Curr Biol. 2013 Jan 7;23(1):94. — View Citation
Castel-Lacanal E, Gerdelat-Mas A, Marque P, Loubinoux I, Simonetta-Moreau M. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in healthy subjects and post-stroke patients. Exp Brain Res. 2007 Jun;180(1):113-22. Epub 2007 Jan 31. — View Citation
Castel-Lacanal E, Marque P, Tardy J, de Boissezon X, Guiraud V, Chollet F, Loubinoux I, Moreau MS. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in the recovery phase of stroke patients. Neurorehabil Neural Repair. 2009 May;23(4):366-72. doi: 10.1177/1545968308322841. Epub 2008 Dec 5. — View Citation
Lum PS, Mulroy S, Amdur RL, Requejo P, Prilutsky BI, Dromerick AW. Gains in upper extremity function after stroke via recovery or compensation: Potential differential effects on amount of real-world limb use. Top Stroke Rehabil. 2009 Jul-Aug;16(4):237-53. doi: 10.1310/tsr1604-237. — View Citation
Marsden J, Greenwood R. Physiotherapy after stroke: define, divide and conquer. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):465-6. — View 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. Erratum in: Circulation. 2012 Jun 5;125(22):e1002. — View Citation
Taylor JL, Martin PG. Voluntary motor output is altered by spike-timing-dependent changes in the human corticospinal pathway. J Neurosci. 2009 Sep 16;29(37):11708-16. doi: 10.1523/JNEUROSCI.2217-09.2009. — View Citation
TWITCHELL TE. The restoration of motor function following hemiplegia in man. Brain. 1951 Dec;74(4):443-80. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Corticospinal Transmission (evoked potentials will be recorded via electromyography.) | Different neural elements will be stimulated and evoked potentials will be recorded via electromyography. | 12 months | |
Secondary | Motor Output | The subject will modulate force by holding a force transducer between the paretic index finger and thumb to control the path of a virtual object through targets displayed on a computer monitor. Subjects will modify force applied to transducer in order to align the path of the object through spatial boundaries of ten targets. All ten targets will appear at once. Ten repetitions of the ten targets (orientation of targets changed slightly each time) will be performed. Performance will be quantified by taking the total actual time the object is overlaid with any part of each target, expressed as a percentage of maximum possible time on target. | 12 months |
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