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NCT Number: NCT05321017

Wrist Extensor MEP Up-conditioning for 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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Blair Dellenbach, MSOT

CONTACT

[email protected]

843-792-6313

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • 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).

Treatment and study plan

MEP Operant Up-conditioning of the Wrist Extensor

Behavioral

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.

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

    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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Blair Dellenbach, MSOT

CONTACT

[email protected]

843-792-6313

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Can Increasing Motor Evoked Potential Size Improve Upper Extremity Motor Function in Individuals With Incomplete Spinal Cord Injury?

Acronym: uMEP

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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