NCT01904591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

July 10, 2013

Last Update Submit

September 12, 2016

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuryAntioxidantstractographyASIA assessment

Outcome Measures

Primary Outcomes (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.

    Time 0 and after 1 year of treatment

Secondary Outcomes (1)

  • Change in ASIA motor score over time.

    Prior to treatment and after 1 year of treatment

Study Arms (1)

Selenium and Vitamin E

EXPERIMENTAL

single arm, all subjects receive both vitamins for 1 year from time zero.

Dietary Supplement: SeleniumDietary Supplement: Vitamin E

Interventions

SeleniumDIETARY_SUPPLEMENT

Selenium 50 micrograms daily per oral 1 year of treatment

Also known as: brand to be determined.
Selenium and Vitamin E
Vitamin EDIETARY_SUPPLEMENT

Vitamin E 400 international units daily per oral 1 year of treatment

Also known as: Brand to be determined
Selenium and Vitamin E

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Rehabilitation Centre At Hamilton General Hospital

Hamilton, Ontario, L8L 0A4, Canada

Location

Related Publications (8)

  • 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.

    PMID: 16582854BACKGROUND

  • 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.

    PMID: 20032030BACKGROUND

  • 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.

    PMID: 3084721BACKGROUND

  • 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.

    PMID: 3555850BACKGROUND

  • 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.

    PMID: 3927795BACKGROUND

  • 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.

    PMID: 22068217BACKGROUND

  • 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.

    PMID: 22772083BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

SeleniumVitamin E

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paul J Stacey, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Shanker Nesathurai, MD, MPh

    Hamilton Health Sciences, McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Scholar/ Fellow: Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 22, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

CA(1)