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Completed

NCT Number: NCT00575536

Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures

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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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhizotomy for children with spasticity

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases

Acronym: Rhizotomy

Important dates

Study start
2006
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2007
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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