Optical Stimulation Rhizotomy Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00575536
First received: December 15, 2007
Last updated: December 20, 2013
Last verified: December 2013

December 15, 2007
December 20, 2013
January 2006
December 2015   (final data collection date for primary outcome measure)
A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00575536 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Optical Stimulation Rhizotomy Study
Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases

The purpose of this study is to determine the safe and effective levels of optical stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery.

The purpose of this study is to determine the safe and effective levels of optical stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery, namely children undergoing selective rhizotomy for treatment of medically refractory spasticity.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

abnormal spinal nerves that have been surgically removed

Probability Sample

Children over the age of 3 and younger than 17 years who have failed appropriate medical therapy for spasticity and are recommended for Rhizotomy surgery

Spasticity
Procedure: Optical Stimulation in Rhizotomy Surgery
Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity
Rhizotomy surgery for children with spasticity
Children with spasticity who need Rhizotomy surgery
Intervention: Procedure: Optical Stimulation in Rhizotomy Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children over the age of 3 and younger than 17 years
  • Children who have failed appropriate medical therapy and are recommended for selective rhizotomy to treat spasticity by the pediatric neurosurgeon
  • Children who would normally undergo electrodiagnostic testing including EMG monitoring for physiologic testing during surgery
  • Surgery must be performed at the Vandebilt University Children's Hospital

Exclusion Criteria:

  • Patients in which a segment of the nerve (up to 2cm) cannot likely be identified at the time of surgery as determined by the pediatric neurosurgeon
  • Children not undergoing routine selective rhizotomy for medically refractory spasticity as determined by the pediatric neurosurgeon
  • Children who are medically unstable to tolerate an additional 20 minutes of experimental testing during the surgery
  • Women who are pregnant will be excluded from this study
Both
3 Years to 17 Years
No
Contact: Peter E Konrad, MD, Ph.D. 615-343-9822 peter.konrad@vanderbilt.edu
Contact: Melba T Isom, AS 615-875-5853 melba.isom@vanderbilt.edu
United States
 
NCT00575536
050822
No
Peter Konrad, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Peter E Konrad, MD, Ph.D. Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Noel B Tulipan, MD Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Chanqing Kao, MD, Ph.D. Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Michael Remple, Ph.D. Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Jonathan Cayce, BS Vanderbilt University
Vanderbilt University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP