Spinal Plasticity to Enhance Motor Retraining After Stroke

Stroke Clinical Trial

Official title:

Plasticity in the Spinal Cord to Enhance Motor Retraining After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645122
• Other study ID #: B2837-W
• Secondary ID: 1617296
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: December 29, 2023

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03638570
• NCT03639116

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Hemiparesis
• Paresis
• Stroke

Intervention

Procedure:
• Noninvasive neuromodulation via paired corticospinal-motoneuronal stimulation (PCMS)
This study is a novel approach to studying neuroplasticity after stroke. Previous work in humans with incomplete spinal cord injury demonstrates that the resulting plasticity transiently enhances motor output, indicating that there is also therapeutic potential. This study will attempt to induce bi-directional plasticity in corticospinal-motoneuronal synapses serving an intrinsic hand muscle of the hemiparetic limb. Control experiments will be completed to provide evidence of the neurophysiological mechanism(s) mediating the effect and to examine behavioral effects.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum In: Circulation. 2012 Jun 5;125(22):e1002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiology	Different neural elements will be stimulated and evoked potentials will be recorded via electromyography. Metrics used to quantify evoked potentials will be used to infer changes in physiological functioning of the nervous system.	12 months
Secondary	Behavior	A visuomotor task will be performed and force signals will be recorded. Metrics used to quantify force signals will be used to infer changes in control processes governing movement.	12 months