NCT04286191

Physiological Changes Induced Through MEP Conditioning in People With SCI

Characterization of Physiological Changes Induced Through Motor-evoked Potential Conditioning in People With Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study team is currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries. Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, the study team will use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort. Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour.

Conditions

• Spinal Cord Injuries
• Neurological Injury
• Paralysis
• Spasticity, Muscle

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Operant Conditioning	This is a training intervention in which the brain-spinal cord-muscle pathways are strengthened in individuals with incomplete spinal cord injury. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot.
COMBINATION_PRODUCT	Control Group	This is the control intervention, or the non-conditioning group. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot.

Timeline

• Start date: 2021-02-22
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2020-02-26
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study