Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures

Completed

• Conditions: Spasticity
• Interventions: Procedure: Rhizotomy for children with spasticity

• Registration Number: NCT00575536
• Lead Sponsor: Vanderbilt University

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-15
• Study First Submitted QC: 2007-12-15
• Study First Posted: 2007-12-18
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rhizotomy for children with spasticity	Rhizotomy for children with spasticity	Children with spasticity needing Rhizotomy surgery

Primary Outcome Measures

Name	Time	Method
A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation	4 hours

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States