Knowledge Forum SCI

Research
Knowledge Forum SCI
2015-Q3 Report
Steering committee
Michael Fehlings (Chairman)
University of Toronto
Toronto, Canada
Start of Term: 01 Apr 2013
End of Term: 30 Jun 2016
Robert Grossman
The Methodist Hospital
Houston, USA
Start of Term: 01 Jan 2012
End of Term: 31 Dec 2017
Bizhan Aarabi
University of Maryland
Baltimore, USA
Start of Term: 01 Jan 2012
End of Term: 31 Dec 2017
Shekar Kurpad
Froedtert & the Medical College of Wisconsin
Milwaukee, USA
Start of Term: 01 Jun 2015
End of Term: 31 May 2018
Brian Kwon
University of British Columbia
Vancouver, Canada
Start of Term: 01 Jun 2015
End of Term: 31 May 2018
James Harrop
Thomas Jefferson University
Philadelphia, USA
Start of Term: 01 Jun 2015
End of Term: 31 May 2018
New Knowledge Forum Manager
María Alvarez Sánchez
AOSpine International
Clavadelerstrasse 8
7270 Davos
Switzerland
T +41 81 414 27 36
[email protected]
Projects
RISCIS
Title: A Multi-Center, Randomized, Placebo-Controlled, DoubleBlinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal
Cord Injury
Principal Investigator: Michael Fehlings
Co-Investigators: Open call for applications completed; eight sites
enrolled.
Aim: The aim of this study is to evaluate efficacy and safety of
Riluzole in the treatment of patients with acute spinal cord injury.
The primary objective is to evaluate the superiority of Riluzole as
compared to placebo, in improving motor outcomes as measured
by ASIA Motor Score at 6 months follow-up, in patients with
acute traumatic spinal cord injury, presenting to hospital less than
12 hours after injury.
Co-sponsoring: AOSpine North America, U.S. Department of
Defense, Christopher and Dana Reeve Foundation, Ontario
Neurotrauma Foundation, Rick Hansen Institute.
Participating sites:
Local PI
Institute
City
Country
Region
Recruited
patients
Surname
Name
Fehlings
Michael
Toronto Western Hospital
Toronto
Canada
NA
Ball
Jonathon
Royal North Shore Hospital
Sydney
Australia
AP
3
Aarabi
Bizhan
University of Maryland
Baltimore
USA
NA
8
Shaffrey
Christopher
University of Virginia
Charlottesville
USA
NA
4
Brooks
Nathaniel
University of Wisconsin
Madison
USA
NA
Harrop
James
Jefferson University
Philadelphia
USA
NA
2
Nassr
Ahmad
The Mayo Clinic
Rochester
USA
NA
4
Brodke
Darrel
University of Utah
Salt Lake City
USA
NA
1
Arnold
Paul
Kansas University Medical Center
Kansas City
USA
NA
3
Kurpad
Shekar
Medical College of Wisconsin
Milwaukee
USA
NA
Theodore
Nicholas
Barrow Neurological Institute at St. Joseph's
Hospital and Medical Center
Phoenix
USA
NA
Ray
Wilson
Washington University
St. Louis
USA
NA
Stanford
Ralph
Prince Wales Hospital
Sydney
Australia
AP
5
Schuster
James
University of Pennsylvania
Philadelphia
USA
NA
5
Ahn
Henry
St. Michael's Hospital
Toronto
Canada
NA
Publications:
•
Abstract submitted: 1
•
Podium presentations: 7
•
Manuscripts submitted: 0
•
Manuscript published: 4
Awards & Nominations:
•
Nominated for the White Cloud Award at the 21st IMAST International 2014.
•
Awarded with the Trauma and Critical Care Third Place Eposter Award.
Status: Executing – data collection
SCI Database Merge
Title: Spinal Cord Injury (SCI) Database Merge: Combining data
of two existing registries (NACTN and STASCIS)
Principal Investigator: Michael Fehlings
Aim: To combine two existing databases on patients with spinal
cord injuries treated surgically (NACTN and STASCIS) and to
assess descriptive data on injury/surgery details, as well as ASIA
score and reported complications.
Publications:
•
Abstracts presented: 0
•
Manuscripts: 0
Awards & Nominations: None
Status: Executing – data analysis
SCI Guideline project (co-sponsoring AOSpine North America)
Title: Development of an Evidence-based Clinical Guideline for
the Treatment of Acute Spinal Cord Injury
Principal Investigator: Michael Fehlings
Co-Investigators: Open call for applications completed; eight sites
enrolled.
Co-sponsoring: AOSpine North America
Aim: A set of systematic reviews will serve as the basis of the
current state of the field. Based on this knowledge, a global
Publications:
•
Abstracts presented: 0
•
Manuscripts: 0
Awards & Nominations: None
Status: Executing – data collection
team of clinical experts in SCI will then go through the
rigorous process of developing evidence-based clinical
guidelines for the treatment of Acute Spinal Cord Injury
specific to the five selected topics:
•
•
•
•
•
Use of methylprednisolone
Timing of decompression
Role and timing of magnetic resonance imaging
Type and timing of anticoagulation
Type and timing of rehabilitation
Publication Summary
Abstracts
Submitted (under review)
1. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). Congress Spine Research Society (CSRS), San
Diego, CA. December 3-5, 2015.
Accepted for Presentation
Podium Presentations:
E-poster Presentations:
1. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). North American Spine Society Annual Meeting.
Chicago, IL. October 14-17, 2015.
Presented
Podium Presentations:
1. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS).
International Meeting on Advance Spine
Techniques (IMAST). Kuala Lumpur, Malaysia. July 8-11,
2015.
2. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS).
ASIA/ISCoS Joint Scientific Meeting
[American Spinal Injuria Association and International
Spinal Cord Society]. Montreal, Canada. May 14-16, 2015.
3. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). AO ONE Conference. Las Vegas, NV.
February 5-7, 2015.
4. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). North American Spine Society (NASS) Meeting.
San Francisco, CA. November 12-15, 2014.
5. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). Congress of Neurological Surgeons (CNS)
Meeting. Boston, MA. October 18-22, 2014.
6. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). International Meeting on Advanced Spine
Techniques (IMAST). Valencia, Spain. July 16-19, 2014.
7. Fehlings MF, Kopjar B, Grossman R. Efficacy and Safety
of Riluzole in Acute Spinal Cord Injury (SCI). Rationale
and Design of AOSpine Phase III Multi-center Double
Blind Randomized Controlled Trial. (RISCIS). SRS 20th
Annual International Meeting on Advanced Spine
Techniques (IMAST). Vancouver, Canada. July 10-13,
2013.
E-poster Presentations:
1. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). Global Spine Congress (GSC) Buenos Aires,
Argentina. May 20-23, 2015.
2. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). American Association of Neurological Surgeons
(AANS) Annual Meeting. Washington DC. May 2-6,
2015.
3. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). AANS/CNS Joint Section on Disorders of the
Spine and Peripheral Nerves. Phoenix, Arizona. March 47, 2015.
4. Fehlings, MF, Kopjar, B, Grossman, R. Efficacy and
Safety of Riluzole in Acute Spinal Cord Injury (SCI).
Rationale and Design of AOSpine Phase III Multi-center
Double Blind Randomized Controlled Trial. (RISCIS).
American Association of Neurological Surgeons (AANS)
Annual Meeting. San Francisco, CA. April 5-9, 2014.
5. Fehlings MF, Grossman R, Wilson J, Frankowski R,
Kopjar B, Burau K, Chow D, Tator C, Teng A, Toups E,
Harrop J, Aarabi B, Shaffrey C, Johns M. The Clinical
Translation of Riluzole for the Treatment of Traumatic
Spinal Cord Injury: Design of a Phase II/III Trial. 63rd
Annual Meeting of the Congress of Neurological Surgeons
(CNS). San Francisco CA, October 19-23, 2013.
6. Fehlings, MF, Kopjar, B, Grossman, R. , Wilson, J.
Efficacy and Safety of Riluzole in Acute Spinal Cord
Injury (SCI). Rationale and Design of AOSpine Phase III
Multi-center Double Blind Randomized Controlled Trial.
(RISCIS). Congress of Neurological Surgeons (CNS)
Annual Meeting. New Orleans, LA. September 27-30,
2015.
Manuscripts
Submitted
Published
1. Nagoshi, N., H. Nakashima and M. G. Fehlings (2015).
"Riluzole as a neuroprotective drug for spinal cord injury:
from bench to bedside." Molecules 20(5): 7775-7789.
2. Fehlings, M. G., H. Nakashima, N. Nagoshi, D. S. Chow,
R. G. Grossman and B. Kopjar (2015). "Rationale, design
and critical end points for the Riluzole in Acute Spinal
Cord Injury Study (RISCIS): a randomized, doubleblinded, placebo-controlled parallel multi-center
trial." Spinal Cord.
3. Fehlings, M. G., J. R. Wilson, R. F. Frankowski, E. G.
Toups, B. Aarabi, J. S. Harrop, C. I. Shaffrey, S. J.
Harkema, J. D. Guest, C. H. Tator, K. D. Burau, M. W.
Johnson and R. G. Grossman (2012). "Riluzole for the
treatment of acute traumatic spinal cord injury: rationale for
and design of the NACTN Phase I clinical trial." J
Neurosurg Spine 17(1 Suppl): 151-156.
4. Tator, C. H., R. Hashimoto, A. Raich, D. Norvell, M. G.
Fehlings, J. S. Harrop, J. Guest, B. Aarabi and R. G.
Grossman (2012). "Translational potential of preclinical
trials of neuroprotection through pharmacotherapy for
spinal cord injury." J Neurosurg Spine 17(1 Suppl): 157229.
Book Chapters
Fehlings, N. Nagoshi, H. Nakashima.
Pathobiology of spinal cord injury. In LR.Vialle, KD.
(Eds.), AOSpine Masters Series Volume 7. New York:
Thieme. (in press).
Riew & M. Ito (Eds.), AOSpine Masters Series Volume 7.
New York: Thieme. (in press).
4. G. Hawryluk, M. Fehlings. Acute non-operative
1. M.
management of traumatic spinal cord injury – state of
the art. In LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine
2. Kwon, B. Serum and CSF Biomarkers to Predict
Functional Recovery after Spinal Cord Injury. In
LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters
Series Volume 7. New York: Thieme. (in press).
5. M. Fehlings, C. Witiw. Role and timing of surgery
3. J. Cohen-Adad, A. Martin, M. Fehlings. Magnetic
for traumatic spinal cord injury – What do we know?
What should we do? In LR.Vialle, KD. Riew & M. Ito
resonance imaging of the injured spinal cord: the
present and the future. In LR.Vialle, KD. Riew & M. Ito
(Eds.), AOSpine Masters Series Volume 7. New York:
Thieme. (in press).
Masters Series Volume 7. New York: Thieme. (in press).
6. J. Wilson, M. Fehlings. Methylprednisolone for acute
spinal cord injury: a re-assessment of the literature.
Is this drug an option? In LR.Vialle, KD. Riew & M. Ito
(Eds.), AOSpine Masters Series Volume 7. New York:
Thieme. (in press).
7. M. Fehlings, C. Ahuja. Neuroprotection of the
injured spinal cord – What does the future hold? In
LR.Vialle, KD. Riew & M. Ito (Eds.), AOSpine Masters
Series Volume 7. New York: Thieme. (in press).
AOSpine International
Clavadelerstrasse 8
7270 Davos Platz
Switzerland
T +41 81 414 27 33
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[email protected]
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