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Lower Limb Function After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
D-Cycloserine
Placebo
Training
Stimulation
Placebo Stimulation
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring SCI

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Shirley Ryan Ability Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

D-Cycloserine/Placebo + Stimulation

Training+Med/Placebo+Stimulation

Training+Med+Stimulation/Placebo Stim

Arm Description

Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.

Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training.

Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation or placebo stimulation followed by training.

Outcomes

Primary Outcome Measures

Changes in motor evoked potential size

Secondary Outcome Measures

Full Information

First Posted
December 11, 2015
Last Updated
June 29, 2021
Sponsor
Shirley Ryan AbilityLab
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02635893
Brief Title
Lower Limb Function After Spinal Cord Injury
Official Title
Lower Limb Function After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2019 (Actual)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
April 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
SCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-Cycloserine/Placebo + Stimulation
Arm Type
Active Comparator
Arm Description
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.
Arm Title
Training+Med/Placebo+Stimulation
Arm Type
Active Comparator
Arm Description
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training.
Arm Title
Training+Med+Stimulation/Placebo Stim
Arm Type
Active Comparator
Arm Description
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation or placebo stimulation followed by training.
Intervention Type
Drug
Intervention Name(s)
D-Cycloserine
Other Intervention Name(s)
Seromycin
Intervention Description
100 mg of Seromycin by mouth will be administered
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Drug
Intervention Description
placebo pill will be administered instead of medication by mouth
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
walking around a designated track at different speeds both forward and backward
Intervention Type
Other
Intervention Name(s)
Stimulation
Intervention Description
magnetic stimulation and electrical stimulation may be applied
Intervention Type
Other
Intervention Name(s)
Placebo Stimulation
Intervention Description
this is a fake stimulation that is administered but will be unknow to the subject.
Primary Outcome Measure Information:
Title
Changes in motor evoked potential size
Time Frame
30 minutes before and 30 minutes after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PT, Phd
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Shirley Ryan Ability Lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lower Limb Function After Spinal Cord Injury

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