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Spinal Cord InjuryNCT01904591

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

A study testing Selenium and Vitamin E in people with Spinal Cord Injury, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injury
What is being tested?
Selenium and Vitamin E
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteCanada
Study dates
Oct 2013to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Regional Rehabilitation Centre At Hamilton General Hospital

    Hamilton, Ontario, L8L 0A4

Other trials in Canada

About this 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.

Read the 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

Being tested
Selenium, Vitamin E
Keywords
Spinal Cord Injury, Antioxidants, tractography, ASIA assessment
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SeleniumDietary supplement

    Also called brand to be determined.

    Selenium 50 micrograms daily per oral

    1 year of treatment

  • Vitamin EDietary supplement

    Also called Brand to be determined

    Vitamin E 400 international units daily per oral

    1 year of treatment

Study groups in NCT01904591
Study groupRoleWhat they receive
Selenium and Vitamin EExperimentalsingle arm, all subjects receive both vitamins for 1 year from time zero.
Receives: Dietary Supplement: Selenium; Dietary Supplement: Vitamin E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Time 0 and after 1 year of treatment

Secondary outcomes (1)

  1. Change in ASIA motor score over time.

    Assess ASIA standardised motor level of SCI patients

    Measured: Prior to treatment and after 1 year of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01904591
Sponsor's protocol ID
SCIantiox1
Status last verified
Sep 2016
First submitted
10 Jul 2013
Last updated
13 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • Pickett GE, Campos-Benitez M, Keller JL, Duggal N. Epidemiology of traumatic spinal cord injury in Canada. Spine (Phila Pa 1976). 2006 Apr 1;31(7):799-805. doi: 10.1097/01.brs.0000207258.80129.03.

    PubMed 16582854

  • Chiu WT, Lin HC, Lam C, Chu SF, Chiang YH, Tsai SH. Review paper: epidemiology of traumatic spinal cord injury: comparisons between developed and developing countries. Asia Pac J Public Health. 2010 Jan;22(1):9-18. doi: 10.1177/1010539509355470.

    PubMed 20032030

  • Hall ED, Wolf DL. A pharmacological analysis of the pathophysiological mechanisms of posttraumatic spinal cord ischemia. J Neurosurg. 1986 Jun;64(6):951-61. doi: 10.3171/jns.1986.64.6.0951.

    PubMed 3084721

  • Hall ED, Braughler JM. Role of lipid peroxidation in post-traumatic spinal cord degeneration: a review. Cent Nerv Syst Trauma. 1986 Fall;3(4):281-94. doi: 10.1089/cns.1986.3.281.

    PubMed 3555850

  • Anderson DK, Demediuk P, Saunders RD, Dugan LL, Means ED, Horrocks LA. Spinal cord injury and protection. Ann Emerg Med. 1985 Aug;14(8):816-21. doi: 10.1016/s0196-0644(85)80064-0.

    PubMed 3927795

  • Robert AA, Zamzami M, Sam AE, Al Jadid M, Al Mubarak S. The efficacy of antioxidants in functional recovery of spinal cord injured rats: an experimental study. Neurol Sci. 2012 Aug;33(4):785-91. doi: 10.1007/s10072-011-0829-4. Epub 2011 Nov 8.

    PubMed 22068217

  • Bastani NE, Kostovski E, Sakhi AK, Karlsen A, Carlsen MH, Hjeltnes N, Blomhoff R, Iversen PO. Reduced antioxidant defense and increased oxidative stress in spinal cord injured patients. Arch Phys Med Rehabil. 2012 Dec;93(12):2223-8.e2. doi: 10.1016/j.apmr.2012.06.021. Epub 2012 Jul 5.

    PubMed 22772083

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Selenium and Vitamin E in people with Spinal Cord Injury, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in MRI Tractography (time frame: Time 0 and after 1 year of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01904591, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.

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