Spinal Cord Injuries and Disorders (SCI/D)NCT07179822
Motoneuron Recruitment and Motor Evoked Potential Up-Conditioning (MEP) in Spinal Cord Injury (SCI)
A study testing Motor Evoked Potential (MEP) Operant Conditioning in people with Spinal Cord Injuries and Disorders (SCI/D) and Spinal Cord Injury, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections. Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries and Disorders (SCI/D), Spinal Cord Injury
- What is being tested?
- Motor Evoked Potential (MEP) Operant Conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 yrs old)
- a history of injury to spinal cord at or above C6
- neurologically stable (>1 year post SCI)
- medical clearance to participate
- weak wrist extension at least unilaterally
- expectation that current medication will be maintained without change for at least 3 months.
- Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted. (Because only neurologically stable subjects will enter this study, medication changes will be unlikely.)
- In participants with bilateral wrist extension weakness in whom Extensor Carpi Radialis (ECR) MEP can be elicited in both arms, the more severely impaired arm is studied. In participants with unilateral wrist weakness or in participants with bilateral wrist weakness in whom an ECR MEP can be elicited in only one arm, that arm is studied.
Who cannot join
- motoneuron injury
- unstable medical condition
- cognitive impairment (because the studied intervention is a learning-based intervention)
- a history of epileptic seizures
- a pre-existing or confounding neurological condition (e.g., history of MS, Stroke, Parkinson's disease)
- metal implants in the cranium
Show all 12Show fewer
- implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)
- no measurable MEP elicited in the ECR
- inability to produce any voluntary ECR EMG activity
- extensive use of functional electrical stimulation to the arm on a daily basis (as it may interfere with or augment the effects of MEP conditioning itself)
- pregnancy (due to changes in posture and potential medical instability)
- inability or unwillingness of subject or legal guardian/representative to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29407
Blair Dellenbach, MSOT, 843-792-6313, stecb@musc.edu
Aiko Thompson, PhD
About this study
Official title: Can MEP Conditioning Improve Corticospinal Recruitment of Motoneurons in Chronic Cervical SCI?
The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections. Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, investigators use a transcranial magnetic stimulator. Investigators hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.
Read the detailed description
Regaining arm/hand function is one of the top priorities of individuals with tetraplegia and is a challenging problem, partly due to the complex nature of upper limb motor function. Through mass practice and conventional therapy, functions can be restored partially, likely through compensation rather than induction of relevant corticospinal plasticity. In such cases, corticospinal recruitment of motoneurons and resulting muscle activation could remain impaired and continue to limit function recovery. In people with incomplete SCI, voluntary activation of the muscles below the injury level is often diminished, due at least partly to impaired motor unit behaviors. Abnormal motoneuron recruitment and motor unit firing, also found in other CNS disorders, would certainly hinder effective production of motor functions. Thus, to enhance upper limb motor rehabilitation beyond what conventional therapy has been able to achieve, a method to improve corticospinal recruitment of a targeted pool of motoneurons would be needed. Here, investigators hypothesize that wrist extensor MEP up-conditioning can improve forearm motor functions in people with cervical SCI by increasing the corticospinal excitability and improving corticospinal recruitment of wrist extensor motoneurons.
- Being tested
- Motor Evoked Potential (MEP) Operant Conditioning
- Keywords
- Movement Disorders, Rehabilitation Studies
- Medical subject headings
- Spinal Cord Injuries, Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Evoked Potential (MEP) Operant ConditioningBehavioural
Operant conditioning is a method to induce behavioral learning based on the consequence (reward) of the behavior. With operant conditioning of the motor evoked potential (MEP), the neuronal excitability and behavior of the corticospinal pathway that involves production of MEP is targeted and trained (i.e., up-trained with up-conditioning). The individual is rewarded only for changing the target muscle's MEP size without changing background muscle activity. Since MEP size reflects the corticospinal excitability at or just before the time of stimulation, during MEP up-conditioning trials, the individual is urged to increase the corticospinal excitability for the target muscle.
| Study group | Role | What they receive |
|---|---|---|
| Motor Evoked Potential (MEP) Operant Conditioning | Experimental | This intervention requires 6 baseline visits and 24 intervention visits, each of which is approximately 1.5 hours. Receives: Behavioral: Motor Evoked Potential (MEP) Operant Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in the size of the Motor Evoked Potential (MEP) from baseline to final conditioning sessions.
MEP from each session is expressed as the percent of the initial MEP size (average MEP size from the 6 baseline sessions). The final MEP size is the fitted estimate of the MEP size at the end of 24 intervention sessions. MEP size is a measurement of the integrity of the corticospinal tract.
Measured: Baseline (average of 6 sessions over 2 weeks) and final phase (average of sessions 19-24 over weeks 7-8 of intervention)
Change in Spinal Cord Independence Measure--version III (SCIM III) score
To measure basic functional independence, we will use the most recent version of the SCIM (SCIM III), which is self-reported and comprises 19 items in three sub-scales: (1) self-care (6 items, subscore 0-20); (2) respiration and sphincter management (4 items, sub-score 0-40); and (3) mobility (9 items, subscore 0-40). The total score ranges from 0-100. The items are weighted in terms of their presumed clinical relevance. SCIM score will be used for calculation of MCID.
Measured: Baseline (Week 0), mid-intervention (Week 5, after session 12), post-intervention (Week 9, after session 24), and follow-up at 1 month (Week 13) and 3 months (Week 21) post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start3 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries and Disorders (SCI/D)Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Aiko Thompson, Medical University of South Carolina
- Investigators
- Aiko Thompson, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179822
- Sponsor's protocol ID
- Pro00145581
- Other IDs
- 1R21HD118383
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can MEP Conditioning Improve Corticospinal Recruitment of Motoneurons in Chronic Cervical SCI?
- ClinicalTrials.gov ID
- NCT07179822
- Acronym / sponsor ID
- Pro00145581
- Keywords
- Movement Disorders, Rehabilitation Studies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Northwestern University, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections. Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, investigators use a transcranial magnetic stimulator. Investigators hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.
Detailed description
Regaining arm/hand function is one of the top priorities of individuals with tetraplegia and is a challenging problem, partly due to the complex nature of upper limb motor function. Through mass practice and conventional therapy, functions can be restored partially, likely through compensation rather than induction of relevant corticospinal plasticity. In such cases, corticospinal recruitment of motoneurons and resulting muscle activation could remain impaired and continue to limit function recovery. In people with incomplete SCI, voluntary activation of the muscles below the injury level is often diminished, due at least partly to impaired motor unit behaviors. Abnormal motoneuron recruitment and motor unit firing, also found in other CNS disorders, would certainly hinder effective production of motor functions. Thus, to enhance upper limb motor rehabilitation beyond what conventional therapy has been able to achieve, a method to improve corticospinal recruitment of a targeted pool of motoneurons would be needed. Here, investigators hypothesize that wrist extensor MEP up-conditioning can improve forearm motor functions in people with cervical SCI by increasing the corticospinal excitability and improving corticospinal recruitment of wrist extensor motoneurons.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motor Evoked Potential (MEP) Operant Conditioning | Experimental | Behavioral: Motor Evoked Potential (MEP) Operant ConditioningThis intervention requires 6 baseline visits and 24 intervention visits, each of which is approximately 1.5 hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (≥18 yrs old)
- a history of injury to spinal cord at or above C6
- neurologically stable (>1 year post SCI)
- medical clearance to participate
- weak wrist extension at least unilaterally
Key exclusion criteria (12 listed)
- motoneuron injury
- unstable medical condition
- cognitive impairment (because the studied intervention is a learning-based intervention)
- a history of epileptic seizures
- a pre-existing or confounding neurological condition (e.g., history of MS, Stroke, Parkinson's disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Evoked Potential (MEP) Operant ConditioningOperant conditioning is a method to induce behavioral learning based on the consequence (reward) of the behavior. With operant conditioning of the motor evoked potential (MEP), the neuronal excitability and behavior of the corticospinal pathway that involves production of MEP is targeted and trained (i.e., up-trained with up-conditioning). The individual is rewarded only for changing the target muscle's MEP size without changing background muscle activity. Since MEP size reflects the corticospinal excitability at or just before the time of stimulation, during MEP up-conditioning trials, the individual is urged to increase the corticospinal excitability for the target muscle. | Behavioural | Motor Evoked Potential (MEP) Operant Conditioning |
Primary outcome
Percent change in the size of the Motor Evoked Potential (MEP) from baseline to final conditioning sessions.
Time frame: Baseline (average of 6 sessions over 2 weeks) and final phase (average of sessions 19-24 over weeks 7-8 of intervention)
MEP from each session is expressed as the percent of the initial MEP size (average MEP size from the 6 baseline sessions). The final MEP size is the fitted estimate of the MEP size at the end of 24 intervention sessions. MEP size is a measurement of the integrity of the corticospinal tract.
Change in Spinal Cord Independence Measure--version III (SCIM III) score
Time frame: Baseline (Week 0), mid-intervention (Week 5, after session 12), post-intervention (Week 9, after session 24), and follow-up at 1 month (Week 13) and 3 months (Week 21) post-intervention.
To measure basic functional independence, we will use the most recent version of the SCIM (SCIM III), which is self-reported and comprises 19 items in three sub-scales: (1) self-care (6 items, subscore 0-20); (2) respiration and sphincter management (4 items, sub-score 0-40); and (3) mobility (9 items, subscore 0-40). The total score ranges from 0-100. The items are weighted in terms of their presumed clinical relevance. SCIM score will be used for calculation of MCID.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aiko Thompson, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Evoked Potential (MEP) Operant Conditioning in people with Spinal Cord Injuries and Disorders (SCI/D) and Spinal Cord Injury, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Occupational Therapist ((843) 792-6313, stecb@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in the size of the Motor Evoked Potential (MEP) from baseline to final conditioning sessions. (time frame: Baseline (average of 6 sessions over 2 weeks) and final phase (average of sessions 19-24 over weeks 7-8 of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.