Corticospinal Function After Spinal Cord Injury

NCT02451683 | Completed

• 2 other identifiers: STU00210458R01NS090622-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator's overall goal is to develop new strategies to test optimization of Spike-timing-dependent plasticity (STDP) doses to maximize strategy to restore upper and lower-limb motor function in individuals with spinal cord injury (SCI). The investigator proposes to use modern electrophysiological methods to enhance the efficacy of residual corticospinal connections. Defining the neural basis by which corticospinal volleys generate muscle responses will provide crucial information required to maximize residual motor output. The investigator's specific goals are to: 1) determine the temporal and spatial organization of corticospinal volleys and motor cortical representations of upper-limb muscles after incomplete cervical SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on reach and grasp movements because of their importance in daily life activities.

Conditions

Spinal Cord Injury

Keywords

SCI

Outcome Measures

Primary Outcomes (1)

• Upper-limb motor function

  measured by functional tests of hand/arm motor function

  5 months

Secondary Outcomes (2)

• Cortical Neurophysiological Outcome

  5 months

• Change in Sensorimotor Function

  5 months

Study Arms (3)

Electrophysiology Assessment of Time Domain

OTHER

Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function

Other: Electrophysiology Assessment of Time Domain; Other: Training with some stimulation

Electrophysiology Assessment of Location

EXPERIMENTAL

Assessment of electrophysiology to examine spatial organization of corticospinal function

Other: Electrophysiology Assessment of Location; Other: Training with some stimulation

Training with some stimulation

ACTIVE COMPARATOR

Training with non-invasive stimulation and training with sham stimulation

Other: Training with some stimulation

Interventions

Electrophysiology Assessment of Time Domain OTHER

Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.

Electrophysiology Assessment of Time Domain

Electrophysiology Assessment of Location OTHER

Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability

Electrophysiology Assessment of Location

Training with some stimulation OTHER

motor task combined with real or sham stimulation

Electrophysiology Assessment of Location; Electrophysiology Assessment of Time Domain; Training with some stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females between 18-85 years,
• Chronic SCI (≥ 6 months post injury),
• Cervical injury at C8 or above,
• Intact or impaired but not absent innervations in dermatomes C6, C7, and C8 using the American Spinal Injury Association sensory scores, and
• Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk
• Male and females between 18-85 years,
• Right handed,
• Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk

You may not qualify if:

• Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
• Any debilitating disease prior to the SCI that caused exercise intolerance
• Premorbid, ongoing major depression or psychosis, altered cognitive status
• History of head injury or stroke
• Pacemaker
• Metal plate in skull
• History of seizures
• Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
• Pregnant females
• Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.
• History of brain tumor and or brain infection

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Monica Perez, PT PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Chair Arms + Hands AbilityLab

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 22, 2015
• Study Start: October 12, 2020
• Primary Completion: December 31, 2025
• Study Completion: January 30, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)