Physiological Changes Induced Through MEP Conditioning in People With SCI

NCT ID: NCT04286191

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2025-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Up-conditioning (UC) Group

Group Type: EXPERIMENTAL

Operant Conditioning

Intervention Type: COMBINATION_PRODUCT

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.

Control (NC) Group

Group Type: SHAM_COMPARATOR

Control Group

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Neurologically stable (>1 year post SCI)
• Medical clearance to participate
• Ability to ambulate at least 10 m with or without an assistive device (except for parallel bars)
• Signs of weak ankle dorsiflexion at least unilaterally
• Expectation that current medication will be maintained without change for at least 3 months; stable use of anti-spasticity medication is accepted

Exclusion Criteria

• motoneuron injury
• known cardiac condition (e.g., history of myocardial infarction, congestive heart failure, pacemaker use)
• medically unstable condition
• cognitive impairment
• history of epileptic seizures
• metal implants in the cranium
• implanted biomedical device in or above the ches (e.g., a cardiac pacemaker, cochlear implant)
• no measurable MEP elicited
• unable to produce any voluntary TA EMG activity
• extensive use of functional electrical stimulation to the leg on a daily basis
• pregnancy (due to changes in weight and posture and potential medical instability)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Aiko Thompson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiko K Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01NS114279-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00091457

Identifier Type: -

Identifier Source: org_study_id