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

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Enrolling

Conditions

Spinal Cord Injuries
Quadriplegia

Treatments

Behavioral: MEP Operant Up-conditioning of the Wrist Extensor

Study type

Interventional

Funder types

Other

Identifiers

NCT05321017
00113108

Details and patient eligibility

About

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.

Enrollment

5 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

MEP Wrist Extensor Up-Conditioning
Experimental group
Treatment:
Behavioral: MEP Operant Up-conditioning of the Wrist Extensor

Trial contacts and locations

1

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Central trial contact

Blair Dellenbach, MSOT

Data sourced from clinicaltrials.gov

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