Lower Limb Function After Spinal Cord Injury

June 29, 2021 updated by: Monica Perez, Shirley Ryan AbilityLab
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • The Shirley Ryan Ability Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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: Stimulation
magnetic stimulation and electrical stimulation may be applied
Other: Training
walking around a designated track at different speeds both forward and backward
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: Stimulation
magnetic stimulation and electrical stimulation may be applied
Other: Training
walking around a designated track at different speeds both forward and backward
Other: Placebo Stimulation
this is a fake stimulation that is administered but will be unknow to the subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in motor evoked potential size
Time Frame: 30 minutes before and 30 minutes after intervention
30 minutes before and 30 minutes after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Collaborators

The Craig H. Neilsen Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2019

Primary Completion (Actual)

March 9, 2021

Study Completion (Actual)

April 11, 2021

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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