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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with chronic cervical spinal cord injuries, aiming to improve arm and hand movement. Participants will undergo 10 weeks of brain stimulation and muscle response training, known as "up-conditioning of the wrist extensor motor evoked potential," to strengthen the connection between the brain, spinal cord, and muscles. Researchers will use MRI scans to observe changes in spinal damage and brain activity during the treatment. Ideal participants have experienced a spinal cord injury at or above the C6 level for more than six months and have weak wrist extension on at least one side. As an Early Phase 1 trial, this research seeks to understand how the treatment functions in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

You will not have to stop taking your current medications, but you should maintain them without change for at least 3 months. Stable use of anti-spasticity medications is allowed.

What prior data suggests that this protocol is safe for individuals with chronic cervical spinal cord injury?

Studies have shown that increasing the activity of certain wrist muscles can be achieved by gently stimulating the brain externally. This type of stimulation is generally well-tolerated. No major negative side effects have been reported from this treatment so far. As this is an early stage of testing, the primary goal is to assess its safety and effectiveness for people with spinal cord injuries. Although data is limited, researchers are focused on ensuring the treatment's safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the up-conditioning for spinal cord injury because it offers a novel approach that focuses on enhancing neural pathways rather than relying on medications or surgeries. Unlike standard treatments, which often involve physical rehabilitation or drugs to manage symptoms, this method directly targets the brain's ability to increase motor evoked potentials (MEPs) through operant conditioning. By providing feedback to patients as they attempt to increase muscle activity, this technique aims to strengthen the connection between the brain and the muscles, potentially leading to improved motor function. This innovative approach could pave the way for more effective rehabilitation strategies for spinal cord injury patients.

What evidence suggests that this protocol is effective for spinal cord injury?

This trial will investigate the effects of operant up-conditioning of the motor evoked potential on wrist muscles. Studies have shown that training can increase the response of wrist muscles to brain signals, improving communication between the brain and muscles. This training might help people with partial spinal cord injuries by strengthening pathways between the brain, spinal cord, and muscles. Research suggests that this approach is feasible and may improve forearm movements for those with spinal cord injuries. Previous findings indicate it can boost muscle activity and enhance movement, such as better control of the wrist and fingers. Although direct data on this specific study is limited, the method and early results appear promising. ^{1 2 4 6 7}

Who Is on the Research Team?

Allison Lewis, DPT, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05321017

Wrist Extensor MEP Up-conditioning for Individuals With ... This is a training intervention in which the brain-spinal cord-muscle pathways are strengthened in individuals with incomplete spinal cord injury. Transcranial ...

2. reporter.nih.gov reporter.nih.gov/project-details/11033806

Project Details - NIH RePORTER Recent studies suggest that MEP up- conditioning is feasible and can increase MEP size that reflects corticospinal excitability. Building on those studies, this ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07179822

Motoneuron Recruitment and Motor Evoked Potential Up ... Here, investigators hypothesize that wrist extensor MEP up-conditioning can improve forearm motor functions in people with cervical SCI by ...

4. withpower.com withpower.com/trial/up-conditioning-for-spinal-cord-injury-b9463

Up-conditioning for Spinal Cord Injury (uMEP2 Trial) ... Up-conditioning of the wrist extensor motor evoked potential will have tolerable side effects & efficacy for patients with Neurological Impairment ...

5. researchgate.net researchgate.net/publication/362206066_Functional_Implications_of_Motor_Evoked_Potential_Operant_Conditioning_of_Wrist_Extensors_in_an_Individual_Poststroke

Functional Implications of Motor Evoked Potential Operant ... In people with chronic incomplete spinal cord injury (SCI), MEP up-conditioning increased TA activity and improved dorsiflexion during locomotion, while in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6907030/

Electrophysiological Outcome Measures in Spinal Cord ... The objective of this systematic review is to describe the reporting of electrophysiological outcome measures in spinal cord injury (SCI) clinical trials

7. mdpi.com mdpi.com/2227-9059/11/10/2602

Comparing Parameters of Motor Potentials Recordings ... This study aimed to investigate the relationships between the different levels and degrees of incomplete spinal cord injury (iSCI) evaluated with magnetic ...