Clinical trial NCT03645122: Spinal Plasticity to Enhance Motor Retraining After Stroke
Official title: Plasticity in the Spinal Cord to Enhance Motor Retraining After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Accident
Hemiparesis
Keywords: Neuromodulation
Transcranial magnetic stimulation (TMS)
Electrical stimulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-08-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor Control & Learning
timeFrame: Measured under each condition, with approximately 2 months required for completion of all conditions.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Michael A. Urbin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.