Up-conditioning for Spinal Cord Injury

(uMEP2 Trial)

Overseen By Recruitment Contact

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Medical University of South Carolina

Must be taking: Anti-spasticity

Disqualifiers: Motoneuron injury, Epileptic seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

11 Participants Needed

Trial Summary

What is the purpose of this trial?

Individuals with chronic cervical spinal cord injury will complete a 10-week training protocol where participants receive non-invasive brain stimulation and feedback on the size of the corresponding muscle response (wrist extensor). Investigators will assess the impact of the brain stimulation training on 1) the brain-to-spinal cord-to-muscle connection and 2) motor functions of the arm and hand. Also, brain and spine magnetic resonance imaging will be collected before and after the training. The imaging measurements will tell investigators about how spinal damage, brain function, and brain structure relate to motor presentation and the response to the training.

Research Team

Allison Lewis, DPT, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for individuals with chronic cervical spinal cord injury, specifically those who have quadriplegia or tetraplegia. Participants should be able to complete a 10-week training protocol and undergo brain and spine imaging before and after the training.

Inclusion Criteria

I have weak wrist extension in at least one arm.

A history of injury to spinal cord at or above C6

I expect my current medication to stay the same for the next 3 months.

Exclusion Criteria

Motoneuron injury

Cognitive impairment

Medically unstable condition

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Participants undergo 6 baseline sessions to measure initial neurophysiological and functional assessments

2 weeks

6 sessions (in-person)

Conditioning

Participants receive 24 conditioning sessions with non-invasive brain stimulation and feedback on muscle response

8 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurophysiological and functional assessments

3 months

Assessments at 1 month and 3 months post-treatment

Treatment Details

Interventions

• Up-conditioning of the wrist extensor motor evoked potential

Trial Overview The study tests if non-invasive brain stimulation combined with feedback on muscle response can improve the connection between the brain, spinal cord, and muscles of the arm and hand in people with spinal cord injuries.

Participant Groups

Group I: Operant Up-Conditioning of the Motor Evoked Potential Experimental Treatment 1 Intervention

The intervention consists of approximately 6 baseline sessions and 24 conditioning sessions at a pace of 3 sessions/week, 1-2 hour duration, over 10 weeks. At the beginning of each session, electromyographic (EMG) recording and nerve stimulating electrodes are placed over the arm. In all sessions, motor evoked potentials (MEPs) will be measured while the sitting subject provides a pre-set level of background muscle EMG with joint angles fixed. In 225 control trials of each baseline sessions and the first 20 trials of conditioning sessions the subject will receive no feedback as to MEP size (i.e., control MEPs). In 225 conditioning trials of each conditioning session, the subject will be encouraged to increase the target muscle MEP, and will receive immediate feedback as to whether MEP size was above a criterion (i.e., whether the trial was a success).

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Doscher Neurorehabilitation Research Program

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+