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Neural Control of Bilateral Movements After SCI

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ClinicalTrials.gov Identifier: NCT02446210
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Monica Perez, University of Miami

Brief Summary:
The long‐term goal is to acquire scientific knowledge that can be used to develop mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed project will examine cortical, corticospinal, and spinal contribution to bilateral hand and arm muscle activity during bilateral movements and spinal contributions to lower limb muscle activity. By comparing changes in different sites within the Central Nervous System (CNS), the investigators may also identify key mechanisms that might be differentially affected by the injury, plasticity, and training.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Magstim 200 Device: Digitimer electrical stimulator Not Applicable

Detailed Description:
If the participant qualifies to take part in this research study, they will be asked to participate in 15-190 study visits,to complete the experimental procedures. These procedures have been broken up into "Phases" and will be completed in any order. Phase I and Phase IIa includes 2-30 total visits - approximately 2-3 hours each to measure arm and finger strength and ability to move. Phase IIb includes 2-30 total visits - approximately 2-3 hours each, to measure leg strength and ability to move. Phase IIIa includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both arms. The participant will be asked to complete a series of tasks such as stacking checkers, turning over cards, squeeze a device to determine how strong their grip is, and see how well they are able to feel sensations on the surface of their skin. The investigators will complete these assessments at pre-determined times during the study participation. Phase IIIb includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both legs. Assessments of the participant's legs will include walking around the lab space, how well they can bend their ankles and hips, and how well they are able to feel sensations on the surface of the participant's skin.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 514 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neural Control of Bilateral Hand, Arm, and Leg Movements After Spinal Cord Injury
Study Start Date : March 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Controls Group
Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation
Device: Magstim 200
Transcranial Magnetic Stimulation

Device: Digitimer electrical stimulator
Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
Other Name: Electrical stimulation

Active Comparator: Spinal Cord Injury Group
Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation
Device: Magstim 200
Transcranial Magnetic Stimulation

Device: Digitimer electrical stimulator
Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
Other Name: Electrical stimulation




Primary Outcome Measures :
  1. Number of participants with reduced motor cortical excitability [ Time Frame: 5 months ]
    Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence


Secondary Outcome Measures :
  1. Number of participants with enhance voluntary motor output in upper limbs [ Time Frame: 5 months ]
    Measured by spike-timing-dependent plasticity

  2. Number of participants with enhance voluntary motor output in lower limbs [ Time Frame: 5 months ]
    Measured by spike-timing-dependent plasticity



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:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria for individuals with SCI:

    • Male and females between ages 18-85 years
    • SCI (≥1 month after injury)
    • Cervical, thoracic or lumbar injury above L5 (tetraplegia)Intact (level 2) or impaired (level 1) but not absent (level 0) lower motor neuron innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the American Spinal Injury Association (ASIA) sensory scores (12)
    • The ability to produce a visible precision grip force with both hands
    • Individuals who have the ability to pick up a small object (large paperclip) from a table independently
    • Ability to perform 30° or more of elbow flexion and extension.
    • The ability to perform a visible contraction with dorsiflexor and hip flexor muscles
    • The ability to ambulate a few steps with or without an assistive device

Inclusion criteria for healthy controls:

  • Male and females between ages 18-85 years
  • Right handed
  • Able to complete precision grips with both hands
  • Able to complete full elbow flexion-extension with both arms.
  • Able to walk and complete lower-limb tests with both legs.

Exclusion Criteria:

  • Exclusion criteria for individuals with SCI and Healthy Controls:

    • 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.

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): NCT02446210


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

Responsible Party: Monica Perez, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02446210     History of Changes
Other Study ID Numbers: 20140997
R01NS076589-01 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Keywords provided by Monica Perez, University of Miami:
SCI
Neural Control
Bilateral Movement
TMS

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