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

September 12, 2016 updated by: Paul Stacey, McMaster University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 0A4
        • Regional Rehabilitation Centre At Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selenium and Vitamin E
single arm, all subjects receive both vitamins for 1 year from time zero.
Dietary supplement: Selenium

Selenium 50 micrograms daily per oral

1 year of treatment

Other Names:
  • brand to be determined.
Dietary supplement: Vitamin E

Vitamin E 400 international units daily per oral

1 year of treatment

Other Names:
  • Brand to be determined

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time 0 and after 1 year of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Prior to treatment and after 1 year of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Paul J Stacey, MD, McMaster University
  • Principal Investigator: Shanker Nesathurai, MD, MPh, Hamilton Health Sciences, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCIantiox1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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