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Lower Limb Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02635893
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Monica Perez, University of Miami

Study Description
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Brief Summary:
This is a randomized, experimental study that examines the physiology of central nervous system pathways contributing to the control of bilateral movements in individuals with spinal cord injuries and promotes the recovery of lower-limb motor function through the use of stimulation and locomotor training.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: D-Cycloserine Drug: Placebo Other: Training Other: Stimulation Other: Placebo Stimulation Phase 4

Detailed Description:

This study plans to examine plasticity in corticospinal synapses of lower-limb muscles. it has been demonstrated that plasticity elicited at corticospinal synapses in the spinal cord result in enhancements in electromyographic (EMG) and force activity in upper-limb muscles. The first step in this proposal is to determine if synaptic plasticity can be elicited in corticospinal projections targeting lower-limb muscles in humans with SC.

We will also study methods to strengthen corticospinal plasticity to promote recovery of leg clearance during training. We will use two novel strategies to enhance plasticity in corticospinal synapses of lower-limb muscles after SCI: a). administration of an N-methyl-D-aspartate (NMDA) receptor agonist (i.e. D-cycloserine), and b). Combine NMDA-induced corticospinal plasticity with training (2D lower limb training and locomotor training. Corticospinal synaptic plasticity is thought to depend on activation of NMDA receptors and D-cycloserine enhances motor skill behaviors in animals and humans will be enhanced by NMDA-induced corticospinal plasticity. An important strength of this aim is the combination of training and strategies that aimed at enhancing the synaptic efficacy of residual corticospinal projections. Training effects on physiological pathways will be explored and correlated with locomotor function


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Corticospinal Excitability of Leg Muscles After Spinal Cord Injury
Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: D-Cycloserine/Placebo + Stimulation
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.
 Drug: D-Cycloserine
100 mg of Seromycin by mouth will be administered
Other Name: Seromycin

Drug: Placebo
placebo pill will be administered instead of medication by mouth
Other Name: Placebo Drug

Other: Stimulation
magnetic stimulation and electrical stimulation may be applied
Active Comparator: Training+Med/Placebo+Stimulation
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training.
 Drug: D-Cycloserine
100 mg of Seromycin by mouth will be administered
Other Name: Seromycin

Drug: Placebo
placebo pill will be administered instead of medication by mouth
Other Name: Placebo Drug

Other: Training
walking around a designated track at different speeds both forward and backward

Other: Stimulation
magnetic stimulation and electrical stimulation may be applied
Active Comparator: Training+Med+Stimulation/Placebo Stim
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation or placebo stimulation followed by training.
 Drug: D-Cycloserine
100 mg of Seromycin by mouth will be administered
Other Name: Seromycin

Other: Training
walking around a designated track at different speeds both forward and backward

Other: Stimulation
magnetic stimulation and electrical stimulation may be applied

Other: Placebo Stimulation
this is a fake stimulation that is administered but will be unknow to the subject.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in motor evoked potential size [ Time Frame: 30 minutes before and 30 minutes after intervention ]

Eligibility Criteria
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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:

  • 4. Inclusion criteria for individuals with SCI:

    • Male and females between ages 18-85 years of age
    • SCI ( ≥1 month of injury)
    • ASIA A, B,C and D
    • SCI above L5
    • Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)
    • Able to ambulate a few steps with or without an assistive device

Inclusion criteria for healthy controls:

  • Male and females between ages 18-85 years of age
  • Able to walk and complete lower-limb tests with both legs

Exclusion Criteria:

Exclusion criteria for individuals with SCI

  • 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,
  • 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, and
  • 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.

Exclusion criteria for healthy controls:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,
  • Any debilitating disease that causes exercise intolerance
  • Premorbid, ongoing major depression or psychosis, altered cognitive status
  • History of head injury or stroke,
  • 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, and
  • 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.
Contacts and Locations
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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): NCT02635893


Contacts
Contact: Monica Perez, PT PhD 305-243-7119 perezmo@miami.edu
Contact: Toshiki Tazoe, PhD 305-243-8771 txt185@miami.edu

Locations
United States, Florida
The Miami Project to Cure Paralysis Recruiting
Miami, Florida, United States, 33136
Contact: Monica Perez, PT PhD    305-243-7119    perezmo@miami.edu   
Contact: Toshiki Tazoe, PhD    305-243-8771    txt185@miami.edu   
Sponsors and Collaborators
University of Miami
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Monica A Perez, PT, Phd University of Miami
More Information
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Responsible Party: Monica Perez, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02635893     History of Changes
Other Study ID Numbers: 20150605
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Monica Perez, University of Miami:
SCI

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Cycloserine
Anti-Infective Agents, Urinary
 Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action