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Lower Limb Function After Spinal Cord Injury

Lower Limb Function After Spinal Cord Injury

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02635893
Enrollment
257
Registered
2015-12-21
Start date
2019-06-21
Completion date
2021-04-11
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

SCI

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

Interventions

DRUGD-Cycloserine

100 mg of Seromycin by mouth will be administered

DRUGPlacebo

placebo pill will be administered instead of medication by mouth

OTHERTraining

walking around a designated track at different speeds both forward and backward

magnetic stimulation and electrical stimulation may be applied

this is a fake stimulation that is administered but will be unknow to the subject.

Sponsors

The Craig H. Neilsen Foundation
CollaboratorOTHER
Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in motor evoked potential size30 minutes before and 30 minutes after intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026