Optical Stimulation Rhizotomy Study

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention
Spasticity
Procedure: Optical Stimulation in Rhizotomy Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

abnormal spinal nerves that have been surgically removed


Estimated Enrollment: 20
Study Start Date: January 2006
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rhizotomy surgery for children with spasticity
Children with spasticity who need Rhizotomy surgery
Procedure: Optical Stimulation in Rhizotomy Surgery
Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575536

Contacts
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

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Peter E Konrad, MD, Ph.D.    615-343-9822    peter.konrad@vanderbilt.edu   
Contact: Melba T Isom    615-343-9822    melba.isom@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University
Investigators
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
  More Information

No publications provided

Responsible Party: Peter Konrad, Director of Functional Neurosurgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00575536     History of Changes
Other Study ID Numbers: 050822
Study First Received: December 15, 2007
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
spasticity
rhizotomy
surgery

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014