Physiological Changes Induced Through MEP Conditioning in People With SCI

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Spasticity, Muscle

Spinal Cord Injuries

Neurological Injury

Paralysis

Treatments

Combination Product: Operant Conditioning

Combination Product: Control Group

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04286191

00091457

1R01NS114279-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)