The Effects of Anti-oxidants on Clinical Outcomes and Radiological Features of Chronic Spinal Cord Injury: A Pilot Study

Study Overview
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Brief Summary
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This study will enroll 10 adults with a chronic spinal cord injury. The investigators will image their damaged motor tracts using MRI tractography scanning, and the investigators will formally assess their ASIA motor level at the outset of the study. Then, the investigators will treat them with one year of 'over the counter' dosage of selenium and vitamin E. These are two vitamins known to be anti-oxidants. After one year the investigators will repeat the MRI scans and ASIA assessments to determine if their has been any change in the appearance of motor tracts on MRI tractography, or in motor level on ASIA exam. As this is a pilot study the investigators are primarily concerned with establishing safety of this intervention, with a view to conducting a larger and more rigorous controlled trial in the future. The investigators also have a small hope that in fact some improvement might be found with vitamin treatment.

Detailed Description
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This is an open label prospective pilot study. The results of this study will assist the researchers in organizing a larger study. The objective of the study is to determine if treatment with over the counter nutrients (Vitamin E and Selenium) may improve recovery in patients with remote traumatic spinal cord injury (SCI). The investigators will enroll 10 adults with remote traumatic spinal cord injury. The participant will have experienced their injury at least one year prior to enrollment, are currently living in the community. Participants may not have any other neurological cause of weakness (i.e. stroke or traumatic brain injury), must be able to undergo MRI scanning, and be able to take the oral medications as prescribed. At the beginning of the study, baseline strength will be measured by a standardized (American Spinal Injury Association) exam. This exam will be repeated one year after taking the treatment. Furthermore specialized radiological imaging (MRI tractography) of the spinal cord will be completed prior to taking the medications, and one year subsequently. MRI tractography is advanced imaging technology that is able to generate quantitive images of the nerve fiber tracts in the spinal cord that control limb movement. We anticipate that treatment with Vitamin E and selenium for a one period year will increase the ASIA motor score and/or increase the nerve density of the nerve tracts in the spinal cord that control limb movement

Official Title
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The Effects of Anti-oxidants on Clinical Outcomes and Radiological Features of Chronic Spinal Cord Injury: A Pilot Study

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Dietary Supplement: Selenium
* Dietary Supplement: Vitamin E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years Spinal cord injury at least on year prior to enrollment Able to swallow pills at described dose and by mouth Able to provide informed consent Able to travel to Hamilton General Hospital for initial and follow-up MRI tractography studies Willing to attend monthly meetings with investigators Exclusion Criteria: Contraindication to MRI scanning such as metal in the body, pacemaker, implanted nerve stimulator, or claustrophobia. Concomitant neurological condition such as stroke, acquired brain injury, peripheral nerve injury Pressure ulcer at time of enrollment into study Uncontrolled autonomic dysreflexia Current usage of anticoagulants Allergy to Selenium or Vitamin E, or present supplementation of both/ either nutrient at study dosage levels. History of Cardiovascular disease (heart attack) Any planned or anticipated surgical treatment for spinal cord injury

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: Selenium and Vitamin E<br>single arm, all subjects receive both vitamins for 1 year from time zero. | Dietary Supplement: Selenium<br>* Selenium 50 micrograms daily per oral 1 year of treatment<br>* Other names: brand to be determined.;Dietary Supplement: Vitamin E<br>* Vitamin E 400 international units daily per oral 1 year of treatment<br>* Other names: Brand to be determined;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MRI Tractography | MRI tractography will be performed at baseline and 1 year post treatment. This imaging modality allows for a detailed picture of the spinal cord motor tracts (the corticospinal tracts). We will measure these tracts (thickness, density, lengths) according to standard tractography protocol and record any change in said measures after treatment. | Time 0 and after 1 year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ASIA motor score over time. | Assess ASIA standardised motor level of SCI patients | Prior to treatment and after 1 year of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Antioxidants, tractography, ASIA assessment