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RecruitingNCT05321017uMEPUpdated Jul 8, 2026

Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury

An interventional study of MEP Operant Up-conditioning of the Wrist Extensor in Spinal Cord Injuries and Quadriplegia, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2021, registered Mar 2022).
  • Started Oct 2021; still recruiting 4 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Spinal Cord Injuries
  • Quadriplegia
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 5 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. a history of injury to spinal cord at or above C6
  2. neurologically stable (>6 mo post SCI)
  3. medical clearance to participate
  4. weak wrist extension at least unilaterally
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. motoneuron injury
  2. medically unstable condition
  3. cognitive impairment
  4. a history of epileptic seizures
  5. metal implants in the cranium
  6. implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)
  7. no measurable MEP elicited in the ECR
  8. unable to produce any voluntary ECR EMG activity
  9. extensive use of functional electrical stimulation to the arm on a daily basis
  10. pregnancy (due to changes in posture and potential medical instability).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    MEP Wrist Extensor Up-Conditioning

    Behavioral: MEP Operant Up-conditioning of the Wrist Extensor

Interventions

  • BehavioralMEP Operant Up-conditioning of the Wrist Extensor

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and final training session (approximately 2.5 months)

  2. 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

    Time frame: change from baseline to immediately after completing the training protocol

  3. 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

    Time frame: change from baseline to immediately after completing the training protocol

  4. 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

    Time frame: change from baseline to immediately after completing the training protocol

  5. 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

    Time frame: change from baseline to immediately after completing the training protocol

  6. 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.

    Time frame: change from baseline to immediately after completing the training protocol

  7. 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

    Time frame: change from baseline to immediately after completing the training protocol

  8. 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.

    Time frame: change from baseline to immediately after completing the training protocol

07

Study locations

1 of 1 sites recruiting
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05321017
Lead sponsor
Medical University of South Carolina
Responsible party
Blair Dellenbach (Occupational Therapist, Medical University of South Carolina) — Principal investigator
First posted
Apr 11, 2022
Start date
Oct 12, 2021
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Blair Dellenbach, MSOT
Contact
stecb@musc.edu
843-792-6313
Blair Dellenbach, MSOT
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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