Spinal Plasticity to Enhance Motor Retraining After Stroke

NCT03645122 | Completed Results DMC

• 2 other identifiers: B2837-W1617296
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Accident; Hemiparesis

Keywords

Neuromodulation; Transcranial magnetic stimulation (TMS); Electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

PCMS REST

EXPERIMENTAL

PCMS will be triggered while the hand/digits are at rest.

Other: Paired corticospinal-motoneuronal stimulation (PCMS)

SHAM

ACTIVE COMPARATOR

SHAM stimulation will be triggered when a criterion level of force stability by the hand/digits is achieved.

Other: Sham stimulation

PCMS ACTIVE

EXPERIMENTAL

PCMS will be triggered when a criterion level of force stability by the hand/digits is achieved.

Other: Paired corticospinal-motoneuronal stimulation (PCMS)

Interventions

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.

PCMS ACTIVE; PCMS REST

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.

SHAM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related 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.

  PMID: 22179539 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Assistant Director for Clinical and Regulatory Affairs
• Organization: VA Pittsburgh Healthcare System

Nikitha.Deepak@va.gov

412-822-3669

Study Officials

• Michael A. Urbin, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: February 4, 2019
• Primary Completion: September 29, 2023
• Study Completion: December 29, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)