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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 : March 5, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Monica Perez, University of Miami

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 18, 2015
Last Update Posted Date March 5, 2019
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
Number of participants with reduced motor cortical excitability [ Time Frame: 5 months ]
Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02446210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
  • Number of participants with enhance voluntary motor output in upper limbs [ Time Frame: 5 months ]
    Measured by spike-timing-dependent plasticity
  • Number of participants with enhance voluntary motor output in lower limbs [ Time Frame: 5 months ]
    Measured by spike-timing-dependent plasticity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural Control of Bilateral Movements After SCI
Official Title  ICMJE Neural Control of Bilateral Hand, Arm, and Leg Movements After Spinal Cord Injury
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.
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  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE
  • Device: Magstim 200
    Transcranial Magnetic Stimulation
  • Device: Digitimer electrical stimulator
    Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
    Other Name: Electrical stimulation
Study Arms
  • Active Comparator: Healthy Controls Group
    Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation
    Interventions:
    • Device: Magstim 200
    • Device: Digitimer electrical stimulator
  • Active Comparator: Spinal Cord Injury Group
    Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation
    Interventions:
    • Device: Magstim 200
    • Device: Digitimer electrical stimulator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2015)
514
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE
Contact: Monica A Perez, PhD, PT 305-243-7119 mperez04@sralab.org
Contact: Kiara Melendez, BS, MPH 305-243-9301 kcm26@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02446210
Other Study ID Numbers  ICMJE 20140997
R01NS076589-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Monica Perez, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Monica A Perez, PhD, PT Univeraity of Miami
PRS Account University of Miami
Verification Date March 2019

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