Nashville, Tennessee 37232


Purpose:

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.


Study 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, namely children undergoing selective rhizotomy for treatment of medically refractory spasticity.


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 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


NCT ID:

NCT00575536


Primary Contact:

Principal Investigator
Peter E Konrad, MD, Ph.D.
Vanderbilt University, Dept. Neurosurgery

Peter E Konrad, MD, Ph.D.
Phone: 615-343-9822
Email: peter.konrad@vanderbilt.edu


Backup Contact:

Email: melba.isom@vanderbilt.edu
Melba T Isom, AS
Phone: 615-875-5853


Location Contact:

Nashville, Tennessee 37232
United States

Peter E Konrad, MD, Ph.D.
Phone: 615-343-9822
Email: peter.konrad@vanderbilt.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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