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Corticospinal Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02451683
Recruitment Status : Recruiting
First Posted : May 22, 2015
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Monica Perez, University of Miami

May 11, 2015
May 22, 2015
November 8, 2017
April 2015
April 2019   (Final data collection date for primary outcome measure)
Upper-limb motor function [ Time Frame: 5 months ]
measured by functional tests of hand/arm motor function
Same as current
Complete list of historical versions of study NCT02451683 on ClinicalTrials.gov Archive Site
  • Cortical Neurophysiological Outcome [ Time Frame: 5 months ]
    measured by the maps area and overlap in millimeters
  • Change in Sensorimotor Function [ Time Frame: 5 months ]
    measured by upper-limb movements scale from 1(dependent) to 7 (independent).
Same as current
Not Provided
Not Provided
 
Corticospinal Function After Spinal Cord Injury
Corticospinal Function After Spinal Cord Injury
The investigator's overall goal is to develop new strategies to enhance the recovery of upper-limb function after 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.

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

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Spinal Cord Injury
  • Other: Electrophysiology Assessment of Time Domain
    Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.
  • Other: Electrophysiology Assessment of Location
    Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability
  • Other: Training with some stimulation
    motor task combined with real or sham stimulation
  • Electrophysiology Assessment of Time Domain
    Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function
    Interventions:
    • Other: Electrophysiology Assessment of Time Domain
    • Other: Training with some stimulation
  • Experimental: Electrophysiology Assessment of Location
    Assessment of electrophysiology to examine spatial organization of corticospinal function
    Interventions:
    • Other: Electrophysiology Assessment of Location
    • Other: Training with some stimulation
  • Active Comparator: Training with some stimulation
    Training with non-invasive stimulation and training with sham stimulation
    Intervention: Other: Training with some stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Same as current
April 2020
April 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
No
Contact: Monica A Perez, PhD, PT 305-243-7119 perezmo@miami.edu
Contact: Sarah Lehmann, BSN sxl938@miami.edu
United States
 
 
NCT02451683
20150069
R01NS090622-01 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: Undecided
Monica Perez, University of Miami
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Monica Perez, PT PhD University of Miami
University of Miami
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP