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Lower Limb Function After Spinal Cord Injury

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Completed
CT.gov ID
NCT02635893
Collaborator
The Craig H. Neilsen Foundation (Other)
257
Enrollment
1
Location
3
Arms
21.7
Actual Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 SCI.

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

Study Type:
Interventional
Actual Enrollment :
257 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Lower Limb Function After Spinal Cord Injury
Actual Study Start Date :
Jun 21, 2019
Actual Primary Completion Date :
Mar 9, 2021
Actual Study Completion Date :
Apr 11, 2021

Arms and Interventions

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 Names:
  • Seromycin

    • Drug: Placebo
    placebo pill will be administered instead of medication by mouth
    Other Names:
  • 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 Names:
  • Seromycin

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

    Primary Outcome Measures

    1. Changes in motor evoked potential size [30 minutes before and 30 minutes after intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. 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

    Locations

    Site City State Country Postal Code
    1 The Shirley Ryan Ability Lab Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Shirley Ryan AbilityLab
    • The Craig H. Neilsen Foundation

    Investigators

    • Principal Investigator: Monica A Perez, PT, Phd, Shirley Ryan AbilityLab

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Monica Perez, Chair Arms + Hands Lab, Shirley Ryan AbilityLab
    ClinicalTrials.gov Identifier:
    NCT02635893
    Other Study ID Numbers:
    • 20150605
    First Posted:
    Dec 21, 2015
    Last Update Posted:
    Jul 1, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Monica Perez, Chair Arms + Hands Lab, Shirley Ryan AbilityLab
    SCI
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Wounds and Injuries
    Cycloserine

    Study Results

    No Results Posted as of Jul 1, 2021