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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 : September 21, 2018
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Monica Perez, University of Miami

December 11, 2015
December 21, 2015
September 21, 2018
October 2015
December 2019   (Final data collection date for primary outcome measure)
Changes in motor evoked potential size [ Time Frame: 30 minutes before and 30 minutes after intervention ]
Same as current
Complete list of historical versions of study NCT02635893 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lower Limb Function After Spinal Cord Injury
Corticospinal Excitability of Leg Muscles After Spinal Cord Injury
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.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Spinal Cord Injury
  • 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
  • Other: Placebo Stimulation
    this is a fake stimulation that is administered but will be unknow to the subject.
  • Active Comparator: D-Cycloserine/Placebo + Stimulation
    Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.
    Interventions:
    • Drug: D-Cycloserine
    • Drug: Placebo
    • Other: Stimulation
  • 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.
    Interventions:
    • Drug: D-Cycloserine
    • Drug: Placebo
    • Other: Training
    • Other: Stimulation
  • 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.
    Interventions:
    • Drug: D-Cycloserine
    • Other: Training
    • Other: Stimulation
    • Other: Placebo Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
257
Same as current
October 2020
December 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Yes
Contact: Monica Perez, PT PhD 305-243-7119 perezmo@miami.edu
Contact: Kiara Melendez, BS, MPH 305-243-9301 kcm26@med.miami.edu
United States
 
 
NCT02635893
20150605
No
Not Provided
Plan to Share IPD: Undecided
Monica Perez, University of Miami
University of Miami
The Craig H. Neilsen Foundation
Principal Investigator: Monica A Perez, PT, Phd University of Miami
University of Miami
September 2018

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