Optical Stimulation Rhizotomy Study

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Vanderbilt University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00575536

First received: December 15, 2007

Last updated: March 22, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2007

Last Updated Date

March 22, 2011

Start Date ^ICMJE

January 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00575536 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Optical Stimulation Rhizotomy Study

Official Title ^ICMJE

Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases

Brief Summary

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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

abnormal spinal nerves that have been surgically removed

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

Condition ^ICMJE

Muscle Spasticity

Intervention ^ICMJE

Procedure: Optical Stimulation in Rhizotomy Surgery

Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity

Study Group/Cohort (s)

Rhizotomy surgery for children with spasticity

Children with spasticity who need Rhizotomy surgery

Intervention: Procedure: Optical Stimulation in Rhizotomy Surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00575536

Other Study ID Numbers ^ICMJE

050822

Has Data Monitoring Committee

Responsible Party

Peter E. Konrad, MD, D. Principal Investigator, Vanderbilt University

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Vanderbilt University

Verification Date

March 2011

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

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