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

NCT05321017 | Recruiting

• 1 other identifier: 00113108
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Quadriplegia

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  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.

  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

  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.

  change from baseline to immediately after completing the training protocol

Study Arms (1)

MEP Wrist Extensor Up-Conditioning

EXPERIMENTAL

Behavioral: MEP Operant Up-conditioning of the Wrist Extensor

Interventions

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.

MEP Wrist Extensor Up-Conditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Blair Dellenbach, MSOT

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blair Dellenbach, MSOT

CONTACT

843-792-6313; stecb@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 11, 2022
• Study Start: October 12, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)