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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries, Quadriplegia

Intervention / Treatment
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* Behavioral: MEP Operant Up-conditioning of the Wrist Extensor


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEP Wrist Extensor Up-Conditioning<br> | Behavioral: MEP Operant Up-conditioning of the Wrist Extensor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |