Motor Evoked Potential Conditioning for Spinal Cord Injury

Overseen By Occupational Therapist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must be taking: Anti-spasticity medications

Disqualifiers: Motoneuron injury, Epileptic seizures, MS, others

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

Compensation: Varies

Number of Visits: 42

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if brain stimulation training, specifically Motor Evoked Potential (MEP) Operant Conditioning, can improve movement issues after spinal cord injuries, particularly when some pathways between the brain and muscles remain intact. Researchers use a transcranial magnetic stimulator to assess its potential in restoring these crucial connections. The trial requires multiple visits over several months. It suits individuals who have sustained a spinal cord injury at the neck level, have been stable for over a year, and have weak wrist extension. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery options for spinal cord injury patients.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires that you maintain your current medication without change for at least 3 months, and stable use of anti-spasticity medication is accepted.

What prior data suggests that this brain stimulation technique is safe for improving movement function?

Research has shown that motor evoked potential (MEP) operant conditioning is generally manageable for participants. In studies involving individuals with long-term, partial spinal cord injuries, this treatment improved muscle movement and walking ability. No serious side effects were reported in these studies, suggesting the treatment is safe for humans, though individual experiences may vary. Potential participants should discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Motor Evoked Potential (MEP) Operant Conditioning for spinal cord injury because it offers a unique approach by leveraging the brain's ability to rewire itself, a process known as neuroplasticity. Unlike standard treatments that might focus on rehabilitation through physical therapy or medication, this technique aims to enhance the communication between the brain and spinal cord directly. By conditioning motor evoked potentials, this method could potentially improve motor function more effectively and sustainably, offering new hope for individuals with spinal cord injuries.

What evidence suggests that Motor Evoked Potential Operant Conditioning is effective for spinal cord injury?

Research has shown that Motor Evoked Potential (MEP) Operant Conditioning, the treatment participants in this trial will receive, can improve movement in individuals with incomplete spinal cord injuries. Studies have found that this treatment boosts muscle activity in the legs, enhancing walking ability. It specifically aids in swinging the leg forward and moving the ankle. Early results suggest that by strengthening connections between the brain and muscles, individuals may regain better control and movement. This approach holds promise for enhancing daily life for those with spinal cord injuries. ^{1 2 6 7 8}

Who Is on the Research Team?

Aiko Thompson, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with incomplete spinal cord injuries, who may still have some brain-to-muscle pathways intact. It aims to help those looking to improve their movement function. Participants will need to commit to approximately 42 visits over 14 weeks and an additional 6 visits in the following 3 months.

Inclusion Criteria

Expectation that current medication will be maintained without change for at least 3 months

History of injury to spinal cord at or above C6

My doctor has approved me to join a clinical trial.

Exclusion Criteria

Implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)

Motoneuron injury

Unstable medical condition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

6 visits (in-person)

Baseline

Baseline measurements of Motor Evoked Potential (MEP) are taken

2 weeks

6 visits (in-person)

Intervention

Participants undergo MEP Operant Conditioning to improve corticospinal recruitment

8 weeks

24 visits (in-person)

Follow-up

Participants are monitored for changes in SCIM III score and MEP size

3 months

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Motor Evoked Potential (MEP) Operant Conditioning

Trial Overview

The study tests a brain stimulation training called Motor Evoked Potential (MEP) Operant Conditioning. This method uses transcranial magnetic stimulation to potentially enhance the function of connections between the brain, spinal cord, and muscles.

How Is the Trial Designed?

Group I: Motor Evoked Potential (MEP) Operant Conditioning Experimental Treatment 1 Intervention

This intervention requires 6 baseline visits and 24 intervention visits, each of which is approximately 1.5 hours.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6442914/

Operant conditioning of the motor-evoked potential and ...

In people with chronic incomplete spinal cord injury (SCI), MEP up-conditioning increased TA activity and improved dorsiflexion during locomotion, while in ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07179822

Motoneuron Recruitment and Motor Evoked Potential Up ...

The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- ...

3.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2020.00552/pdf

Can Operant Conditioning of EMG-Evoked Responses ...

Up until now, the majority of evoked potential operant conditioning studies have been done in SCI (68, 80, 82, 92, 99, 141–145), and its ...

4.

journals.physiology.org

journals.physiology.org/doi/prev/20190109-aop/pdf/10.1152/jn.00557.2018

Operant conditioning of the motor evoked potential and locomotion

reflex conditioning after spinal cord injury. J ... corticospinal system and voluntary motor control in motor-incomplete human spinal cord injury. ... potential ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30625010/

Operant conditioning of the motor-evoked potential ... - PubMed

In participants with SCI, MEP up-conditioning increased TA activity during the swing-to-swing stance transition phases and ankle joint motion ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1878747923010528

Clinical Translation of Spinal Reflex Operant Conditioning

This paper reviews the value of spinal reflexes and the therapeutic promise of spinal reflex operant conditioning protocols.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30207863/

Operant conditioning of the tibialis anterior motor evoked ...

These results indicate that MEP up-conditioning can facilitate corticospinal excitation, which is essential for enhancing motor function recovery after SCI.

8.

journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/19417381241257258

Conditioning of Motor Evoked Responses After Anterior ...

Operant conditioning of motor evoked torque (MEP TORQUE) can directly target the corticospinal pathway in patients with anterior cruciate ligament (ACL) ...