Spinal Cord InjuriesuMEPNCT05321017
Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury
A study testing MEP Operant Up-conditioning of the Wrist Extensor in people with Spinal Cord Injuries and Quadriplegia, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Quadriplegia
- What is being tested?
- MEP Operant Up-conditioning of the Wrist Extensor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a history of injury to spinal cord at or above C6
- neurologically stable (>6 mo 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. In participants with bilateral wrist extension weakness, the more severely impaired arm is studied.
Who cannot join
- motoneuron injury
- medically unstable condition
- cognitive impairment
- a history of epileptic seizures
- metal implants in the cranium
- implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)
Show all 10Show fewer
- no measurable MEP elicited in the ECR
- unable to produce any voluntary ECR EMG activity
- extensive use of functional electrical stimulation to the arm on a daily basis
- pregnancy (due to changes in posture and potential medical instability).
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, 29425
Blair Dellenbach, MSOT, 843-792-6313, stecb@musc.edu
About this study
Official title: Can Increasing Motor Evoked Potential Size Improve Upper Extremity Motor Function in Individuals With Incomplete Spinal Cord Injury?
The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm.
It is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI).
This study requires 30 visits, and each visit will last approximately 1.5 hours.
- Conditions
- Spinal Cord Injuries, Quadriplegia
- Being tested
- MEP Operant Up-conditioning of the Wrist Extensor
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEP Operant Up-conditioning of the Wrist ExtensorBehavioural
This is a training intervention in which the brain-spinal cord-muscle pathways are strengthened in individuals with incomplete spinal cord injury. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the wrist extensor (extensor carpi radialis), the muscle the bends the wrist back.
| Study group | Role | What they receive |
|---|---|---|
| MEP Wrist Extensor Up-Conditioning | Experimental | Not described Receives: Behavioral: MEP Operant Up-conditioning of the Wrist Extensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the Motor Evoked Potential
An increased average MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
Measured: Baseline and final training session (approximately 2.5 months)
Change in ability to move the arm as measured by the Action Research Arm Test (ARAT). Maximum score of 57 points
An increase in ARAT score indicates an improvement in the ability to move the arm
Measured: change from baseline to immediately after completing the training protocol
Change in ability to move the arm as measured by the Fugl-Meyer Assessment (FMA)
An increase in the FMA score indicates better movement of the arm. Maximum score of 66 points
Measured: change from baseline to immediately after completing the training protocol
Change in gross manual dexterity as measured by the Box and Block Test (BBT)
An increased number of blocks moved in 60s indicates increased gross manual dexterity
Measured: change from baseline to immediately after completing the training protocol
Change in fine motor ability and finger dexterity as measured by the Nine Hole Peg Test
Decreased amount of time (s) to place and remove pegs in a peg board indicates improved fine motor ability and finger dexterity
Measured: change from baseline to immediately after completing the training protocol
Change in strength as measured by Manual Muscle Testing (MMT)
Increased score on MMT indicates increased strength in the muscle being tested. The examiner grades the patient's strength on a 0 to 5 scale. 0: No muscle activation; 1: Trace muscle activation, such as a twitch, without achieving full range of motion; 2: Muscle activation with gravity eliminated, achieving full range of motion; 3: Muscle activation against gravity, full range of motion; 4: Muscle activation against some resistance, full range of motion; 5: Muscle activation against examiner's full resistance, full range of motion.
Measured: change from baseline to immediately after completing the training protocol
Change in sensation on the back and palm of the hand as measured by the Semmes Weinstein Monofilament Test
Ability to detect increasingly thinner monofilaments indicates increased sensation
Measured: change from baseline to immediately after completing the training protocol
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.
Measured: change from baseline to immediately after completing the training protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start12 Oct 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 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 InjuriesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blair Dellenbach, Medical University of South Carolina
- Investigators
- Blair Dellenbach, MSOT, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321017
- Sponsor's protocol ID
- 00113108
- Acronym
- uMEP
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Increasing Motor Evoked Potential Size Improve Upper Extremity Motor Function in Individuals With Incomplete Spinal Cord Injury?
- ClinicalTrials.gov ID
- NCT05321017
- Acronym / sponsor ID
- uMEP / 00113108
- Conditions
- Spinal Cord Injuries, Quadriplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Apr 2022 (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 study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm.
It is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI).
This study requires 30 visits, and each visit will last approximately 1.5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEP Wrist Extensor Up-Conditioning | Experimental | Behavioral: MEP Operant Up-conditioning of the Wrist Extensor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a history of injury to spinal cord at or above C6
- neurologically stable (>6 mo 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. In participants with bilateral wrist extension weakness, the more severely impaired arm is studied.
Key exclusion criteria (10 listed)
- motoneuron injury
- medically unstable condition
- cognitive impairment
- a history of epileptic seizures
- metal implants in the cranium
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 |
|---|---|---|
| MEP Operant Up-conditioning of the Wrist ExtensorThis is a training intervention in which the brain-spinal cord-muscle pathways are strengthened in individuals with incomplete spinal cord injury. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the wrist extensor (extensor carpi radialis), the muscle the bends the wrist back. | Behavioural | MEP Wrist Extensor Up-Conditioning |
Primary outcome
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the Motor Evoked Potential
Time frame: Baseline and final training session (approximately 2.5 months)
An increased average MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
Change in ability to move the arm as measured by the Action Research Arm Test (ARAT). Maximum score of 57 points
Time frame: change from baseline to immediately after completing the training protocol
An increase in ARAT score indicates an improvement in the ability to move the arm
Change in ability to move the arm as measured by the Fugl-Meyer Assessment (FMA)
Time frame: change from baseline to immediately after completing the training protocol
An increase in the FMA score indicates better movement of the arm. Maximum score of 66 points
Change in gross manual dexterity as measured by the Box and Block Test (BBT)
Time frame: change from baseline to immediately after completing the training protocol
An increased number of blocks moved in 60s indicates increased gross manual dexterity
Change in fine motor ability and finger dexterity as measured by the Nine Hole Peg Test
Time frame: change from baseline to immediately after completing the training protocol
Decreased amount of time (s) to place and remove pegs in a peg board indicates improved fine motor ability and finger dexterity
Change in strength as measured by Manual Muscle Testing (MMT)
Time frame: change from baseline to immediately after completing the training protocol
Increased score on MMT indicates increased strength in the muscle being tested. The examiner grades the patient's strength on a 0 to 5 scale. 0: No muscle activation; 1: Trace muscle activation, such as a twitch, without achieving full range of motion; 2: Muscle activation with gravity eliminated, achieving full range of motion; 3: Muscle activation against gravity, full range of motion; 4: Muscle activation against some resistance, full range of motion; 5: Muscle activation against examiner's full resistance, full range of motion.
Change in sensation on the back and palm of the hand as measured by the Semmes Weinstein Monofilament Test
Time frame: change from baseline to immediately after completing the training protocol
Ability to detect increasingly thinner monofilaments indicates increased sensation
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
Time frame: change from baseline to immediately after completing the training protocol
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.
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 8 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.
Blair Dellenbach, MSOT 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 MEP Operant Up-conditioning of the Wrist Extensor in people with Spinal Cord Injuries and Quadriplegia, 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 5 inclusion and 10 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 8 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 Blair Dellenbach, MSOT (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?
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the Motor Evoked Potential (time frame: Baseline and final training session (approximately 2.5 months)). The study lists 8 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 8 Jul 2026.