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

NCT ID: NCT01904591

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-07-31

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.

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

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selenium and Vitamin E

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

Group Type: EXPERIMENTAL

Selenium

Intervention Type: DIETARY_SUPPLEMENT

Selenium 50 micrograms daily per oral

1 year of treatment

Vitamin E

Intervention Type: DIETARY_SUPPLEMENT

Vitamin E 400 international units daily per oral

1 year of treatment

Interventions

Selenium

Selenium 50 micrograms daily per oral

1 year of treatment

Intervention Type: DIETARY_SUPPLEMENT

Vitamin E

Vitamin E 400 international units daily per oral

1 year of treatment

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

brand to be determined.; Brand to be determined

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Paul Stacey

Clinical Scholar/ Fellow: Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul J Stacey, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Shanker Nesathurai, MD, MPh

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences, McMaster University

Locations

Regional Rehabilitation Centre At Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 16582854 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20032030 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3084721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3555850 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3927795 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22068217 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22772083 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

SCIantiox1

Identifier Type: -

Identifier Source: org_study_id