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Lower Limb Function After Spinal Cord Injury

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Shirley Ryan AbilityLab

Status and phase

Completed
Phase 4

Conditions

Spinal Cord Injury

Treatments

Other: Placebo Stimulation
Drug: Placebo
Other: Stimulation
Drug: D-Cycloserine
Other: Training

Study type

Interventional

Funder types

Other

Identifiers

NCT02635893
20150605

Details and patient eligibility

About

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.

Full 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

Enrollment

257 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

257 participants in 3 patient groups

D-Cycloserine/Placebo + Stimulation
Active Comparator group
Description:
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.
Treatment:
Other: Stimulation
Drug: D-Cycloserine
Drug: Placebo
Training+Med/Placebo+Stimulation
Active Comparator group
Description:
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training.
Treatment:
Other: Training
Other: Stimulation
Drug: D-Cycloserine
Drug: Placebo
Training+Med+Stimulation/Placebo Stim
Active Comparator group
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.
Treatment:
Other: Training
Other: Stimulation
Drug: D-Cycloserine
Other: Placebo Stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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