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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904591
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Paul Stacey, McMaster University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Dietary Supplement: Selenium Dietary Supplement: Vitamin E Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Anti-oxidants on Clinical Outcomes and Radiological Features of Chronic Spinal Cord Injury: A Pilot Study
Study Start Date : October 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


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 Name: brand to be determined.

Dietary Supplement: Vitamin E

Vitamin E 400 international units daily per oral

1 year of treatment

Other Name: Brand to be determined




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904591


Locations
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Canada, Ontario
Regional Rehabilitation Centre At Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 0A4
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Paul J Stacey, MD McMaster University
Principal Investigator: Shanker Nesathurai, MD, MPh Hamilton Health Sciences, McMaster University
Publications:
The Incidence and Prevalence of Spinal Cord Injury in Canada: Overview and estimates based on current evidence: Joint publication of Urban Futures and The Rick Hansen Institute. Urban Futures Institute, 2010.

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Responsible Party: Paul Stacey, Clinical Scholar/ Fellow: Physical Medicine and Rehabilitation, McMaster University
ClinicalTrials.gov Identifier: NCT01904591    
Other Study ID Numbers: SCIantiox1
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Keywords provided by Paul Stacey, McMaster University:
Spinal Cord Injury
Antioxidants
tractography
ASIA assessment
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Vitamin E
Selenium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements