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

NCT ID: NCT05321017

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MEP Wrist Extensor Up-Conditioning

Group Type: EXPERIMENTAL

MEP Operant Up-conditioning of the Wrist Extensor

Intervention Type: 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.

Interventions

MEP 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Blair Dellenbach

Occupational Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Blair Dellenbach, MSOT

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Blair Dellenbach, MSOT

Role: CONTACT

stecb@musc.edu

843-792-6313

Facility Contacts

Blair Dellenbach, MSOT

Role: primary

stecb@musc.edu

843-792-6313

Other Identifiers

00113108

Identifier Type: -

Identifier Source: org_study_id