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Completed

NCT Number: NCT01904591

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Rehabilitation Centre At Hamilton General Hospital

Hamilton, Ontario, L8L 0A4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selenium

Dietary Supplement

Selenium 50 micrograms daily per oral

1 year of treatment

Other names: brand to be determined.

Vitamin E

Dietary Supplement

Vitamin E 400 international units daily per oral

1 year of treatment

Other names: Brand to be determined

Primary outcomes

  1. Change in MRI Tractography

    Time frame: Time 0 and after 1 year of treatment

    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.

Secondary outcomes

  1. Change in ASIA motor score over time.

    Time frame: Prior to treatment and after 1 year of treatment

    Assess ASIA standardised motor level of SCI patients

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2013
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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