Neurosurgical Trials Methodology Center
Dr. John Kestle is the Principle Investigator for a new FDA shunt design trial. The trial will assess the safety of a new programmable shunt system made by Medtronic PS Medical called the Strata® Valve. It is based on the design of the Delta® valve but allows the valve pressure setting to be changed by magnets placed over the shunt valve. Ten centers in the United States and Canada are participating.
What is the Neurosurgical Trials Methodology Center?
The mandate of the the NTMC is to promote excellence in clinical research in neurosurgery. The primary focus is randomized clinical trials and the Center's primary function is to coordinate multi-centre trials. The Center is also available for consultation on neurosurgical clinical research projects, particularly consultations regarding the design of projects in their early stages.
Who are we?
Director: Dr. John Kestle is the Director of the NTMC. Dr. Kestle is a pediatric neurosurgeon, Professor at the University of Utah. He has a master's degree in clinical epidemiology and biostatistics from McMaster University and has been the principal investigator on several multi-center trials in hydrocephalus.
Project Manager: Patty Mavor is the Project Manager for the current studies being run out of the NTMC. She is new to the NTMC and brings years of organizational and managerial skills to the position. Patty has a major role in protocol preparation, data management and development of the center.
Where are we?
The personnel at the NTMC are located in the Division of Pediatric Neurosurgery, Primary Children's Medical Center. Correspondence can be sent to:
Neurosurgical Trials Methodology Center
Primary Children's Medical Center
100 N. Mario Capecchi Dr., Ste. 1475
Salt Lake City, UT 84113
801-662-5340 Office
801-662-5370 Fax
Projects Based at the NTMC
1. A randomized trial of ventriculoperitoneal shunt designs.
This multi-center randomized trial in pediatric Neurosurgery compared three VP shunt valves. There were 13 participating centers across North America and Europe. Patient accrual close date: October 31, 1995. Initial follow-up close date: October 31, 1996. Extended follow-up closed August 31, 1999.
Related publications:
1. Drake J, Kestle J: Pediatric Hydrocephalus Treatment Evaluation Group: Determining the best CSF shunt valve design: The Pediatric Valve Design Trial. Neurosurg 1996; 38: 604-606.
2. Drake J, Kestle J and the Pediatric Hydrocephalus Treatment Evaluation Group: Rationale and methodology for the multi-center pediatric cerebrospinal fluid shunt design trial. Child's Nerv Syst 1996; 12: 434-447.
3. Drake J, Kestle J, Milner R, et al: Randomized trial of cerebrospinal fluid shunt design in pediatric hydrocephalus. Neurosurg 1998; 43: 294-305.
4. Kestle J, Milner R, Drake J: An assessment of observer bias in the Shunt Design Trial. Pediatr Neurosurg 1999; 30: 57-61.
5. Kestle J, Milner R, Drake J: The Shunt Design Trial: Variation in surgical experience didn't influence shunt survival. Pediatric Neurosurg 1999; 30: 283-287.
Funding:
* $254,598.40 = Grants
* $ 68,827.50 = Industry Support
2. A randomized trial of TES after rhizotomy in patients with cerebral palsy.
This is a single institution randomized trial, which has been completed and is published.
Related publications:
1. Steinbok P, Reiner A, Kestle J: Therapeutic electric stimulation following selective posterior rhizotomy in children with spastic diplegia due to cerebral palsy: a randomized clinical trial. Developmental Medicine and Child Neurology 1997; 39: 515-520.
Funding:
* $43,995.00 = Grants
3. Endoscopic shunt insertion trial.
In this trial patients who require shunt insertion are randomized to surgery with or without a "shunt placement scope." Randomization began in August 1996 and closed November 30, 1999. Sixteen centers in North America and Europe participated. Follow-up will close November 30, 2000.
Raleted publication: None yet.
Funding:
* $311,370 = Grants
4. Strata valve clinical study.
This is a non-randomized prospective cohort study assessing Medtronics adjustable valve (Strata). Accrual began April 2000. Up to 190 insertion patients and 60 revision patients will be enetered and followed for a minimum of one year.
Funding: Medtronic PS Medical
5. Management of shunt infection.
This trial is in the planning stage. The idea is to assess whether the treatment of shunt infection can be safely shortened. An investigator meeting to plan the study was held in Salt Lake City, February, 2000. A pilot study of short treatment of shunt infection will be the first step.
Training Opportunities
Two neurosurgical trainees have spent time (1 year) associated with the NTMC. Both obtained an MSc related to clinical research and biostatistics. They obtained experience in the planning and daily operations of multi-center clinical trials in Neurosurgery and conducted related clinical research.
1997-1998 Hugh Garton, M.D.
1999-2000 William Whitehead, MD
Interested candidates should contact: Dr. John Kestle
Participating Centers 1993-2000 (n=21)
| Center |
SDT
|
ESIT
|
||
| Beth Israel, NY |
5
|
|||
| Birmingham, AL |
13
|
63
|
||
| Birmingham, U.K. |
9
|
|||
| Calgary, Alberta, CN |
8
|
|||
| Cornell, NY |
5
|
|||
| Detroit, MI |
28
|
|||
| Jackson, MS |
11
|
1
|
||
| Little Rock, AR |
52
|
53
|
||
| Madison, WI |
8
|
|||
| Minneapolis, MN |
10
|
|||
| Montreal, CN |
7
|
|||
| NYU |
14
|
|||
| Paris, France |
102
|
|||
| Phoenix, AZ |
12
|
|||
| Pittsburgh, PA |
32
|
|||
| Portland, OR |
28
|
36
|
||
| Salt Lake City, UT |
50
|
|||
| Toronto, Ontario, CN |
53
|
21
|
||
| Utrecht |
7
|
1
|
||
| Vancouver, B.C., CN |
45
|
49
|
||
| Washington, D.C. |
8
|
|||
| Total Patients Entered |
344
|
387
|
||
Total: 731