Corticospinal Function After Spinal Cord Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Other: Electrophysiology Assessment of Time Domain; Other: Training with some stimulation; Other: Electrophysiology Assessment of Location

Detailed Description

This study will determine the temporal organization of corticospinal volleys during reach and grasp movements. Multiple descending volleys in the corticospinal tract generate multiple peaks in muscle responses (indirect (I)-waves). I-waves are a mechanism by which corticospinal neurons are transynaptically activated at periodic intervals of ~1.5 ms. This periodic activation contributes to the recruitment of spinal motoneurons and generation of movement. we will use paired-TMS to examine I-waves in surface EMG recordings from upper-limb muscles during reach and grasp movements.

We will also identify motor cortical maps of upper-limb muscles involved in reach and grasp movements. We will use TMS guided by a frameless neuronavigation system to define the size and location of motor cortical maps of upper-limb muscles during reach and grasp movements. We will be able to determine overlaps and functional interactions between distal and proximal arm motor cortical representations. Our preliminary data shows that finger and biceps cortical maps largely overlap during reach and grasp movements in controls but considerable less in patients

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica A Perez, PhD, PT; Phone Number: 312-238-2886; Email: mperez04@sralab.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Shirley Ryan AbilityLab
      • Contact: PhD
      • Contact: Monica A Perez, PhD, PT; Phone Number: 312-238-2886; Email: mperez04@sralab.org
      • Principal Investigator: Monica A Perez, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion criteria for individuals with SCI:

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

Inclusion criteria for healthy controls:

1. Male and females between 18-85 years,
2. Right handed,
3. Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk

Exclusion Criteria:

• Exclusion criteria for individuals with SCI and Healthy Controls:

  1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  2. Any debilitating disease prior to the SCI that caused exercise intolerance
  3. Premorbid, ongoing major depression or psychosis, altered cognitive status
  4. History of head injury or stroke
  5. Pacemaker
  6. Metal plate in skull
  7. History of seizures
  8. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
  9. Pregnant females
  10. 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.
  11. History of brain tumor and or brain infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Electrophysiology Assessment of Time Domain; Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function	Other: Electrophysiology Assessment of Time Domain; Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.; Other: Training with some stimulation; motor task combined with real or sham stimulation
Experimental: Electrophysiology Assessment of Location; Assessment of electrophysiology to examine spatial organization of corticospinal function	Other: Training with some stimulation; motor task combined with real or sham stimulation; Other: Electrophysiology Assessment of Location; Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability
Active Comparator: Training with some stimulation; Training with non-invasive stimulation and training with sham stimulation	Other: Training with some stimulation; motor task combined with real or sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper-limb motor function	measured by functional tests of hand/arm motor function	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical Neurophysiological Outcome	measured by the maps area and overlap in millimeters	5 months
Change in Sensorimotor Function	measured by upper-limb movements scale from 1(dependent) to 7 (independent).	5 months

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Monica Perez, PT PhD, Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimated): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: SCI
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: STU00210458; R01NS090622-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No