NCT02635893

Lower Limb Function After Spinal Cord Injury

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	D-Cycloserine	100 mg of Seromycin by mouth will be administered
DRUG	Placebo	placebo pill will be administered instead of medication by mouth
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.

Timeline

• Start date: 2019-06-21
• Primary completion: 2021-03-09
• Completion: 2021-04-11
• First posted: 2015-12-21
• Last updated: 2021-07-01

Locations

1 site across 1 country: United States