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Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures (Rhizotomy)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anita Mahadevan-Jansen, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00575536
First received: December 15, 2007
Last updated: April 13, 2017
Last verified: April 2017
December 15, 2007
April 13, 2017
January 2006
January 2020   (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 ]
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 in Peripheral Nerves for Select Rhizotomy Procedures
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: Rhizotomy for children with spasticity
Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity
Rhizotomy for children with spasticity
Children with spasticity needing Rhizotomy surgery
Intervention: Procedure: Rhizotomy for children with spasticity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
19
January 2020
January 2020   (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 Vanderbilt 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
Sexes Eligible for Study: All
3 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00575536
050822
No
Studies a U.S. FDA-regulated Drug Product: No
Plan to Share IPD: No
Anita Mahadevan-Jansen, Vanderbilt University
Vanderbilt University
Not Provided
Study Chair: Peter E Konrad, MD, Ph.D. 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
Vanderbilt University
April 2017

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