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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 : September 21, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Monica Perez, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: Electrophysiology Assessment of Time Domain Other: Electrophysiology Assessment of Location Other: Training with some stimulation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Corticospinal Function After Spinal Cord Injury
Study Start Date : April 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: 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

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




Primary Outcome Measures :
  1. Upper-limb motor function [ Time Frame: 5 months ]
    measured by functional tests of hand/arm motor function


Secondary Outcome Measures :
  1. Cortical Neurophysiological Outcome [ Time Frame: 5 months ]
    measured by the maps area and overlap in millimeters

  2. Change in Sensorimotor Function [ Time Frame: 5 months ]
    measured by upper-limb movements scale from 1(dependent) to 7 (independent).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451683


Contacts
Contact: Monica A Perez, PhD, PT 305-243-7119 perezmo@miami.edu
Contact: Kiara Melendez, BS, MPH 305-243-9301 kcm26@med.miami.edu

Locations
United States, Florida
The Miami Project to Cure Paralysis Recruiting
Miami, Florida, United States, 33136
Contact: Monica A Perez, PhD, PT    305-243-7119    perezmo@miami.edu   
Contact: Toshiki Tazoe, PhD    305-243-8771    txt185@miami.edu   
Principal Investigator: Monica A Perez, PhD         
Sponsors and Collaborators
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Monica Perez, PT PhD University of Miami

Responsible Party: Monica Perez, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02451683     History of Changes
Other Study ID Numbers: 20150069
R01NS090622-01 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Monica Perez, University of Miami:
SCI

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System