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

McMaster University

Status

Completed

Conditions

Spinal Cord Injury

Treatments

Dietary Supplement: Vitamin E

Dietary Supplement: Selenium

Study type

Interventional

Funder types

Other

Identifiers

NCT01904591

SCIantiox1

Details and patient eligibility

About

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.

Full description

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

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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