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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05321017
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : March 31, 2023
Sponsor:
Information provided by (Responsible Party):
Blair Dellenbach, Medical University of South Carolina

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Quadriplegia Behavioral: MEP Operant Up-conditioning of the Wrist Extensor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Increasing Motor Evoked Potential Size Improve Upper Extremity Motor Function in Individuals With Incomplete Spinal Cord Injury?
Actual Study Start Date : October 12, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MEP Wrist Extensor Up-Conditioning Behavioral: 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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321017


Contacts
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Contact: Blair Dellenbach, MSOT 843-792-6313 stecb@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Blair Dellenbach, MSOT    843-792-6313    stecb@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Blair Dellenbach, MSOT Medical University of South Carolina
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Responsible Party: Blair Dellenbach, Occupational Therapist, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05321017    
Other Study ID Numbers: 00113108
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: March 31, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations