Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases

Vanderbilt University1 site in 1 country19 target enrollmentJanuary 2006

ConditionsSpasticity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spasticity
Sponsor: Vanderbilt University
Enrollment: 19
Locations: 1
Primary Endpoint: A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

November 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Vanderbilt University

Responsible Party

Principal Investigator

Anita Mahadevan-Jansen

Professor Biomedical Engineering and Neurosurgery

Vanderbilt University

Eligibility 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 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