Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spasticity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Rhizotomy for children with spasticity

Children with spasticity needing Rhizotomy surgery

Rhizotomy for children with spasticity

Intervention Type PROCEDURE

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

Interventions

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Rhizotomy for children with spasticity

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No