View Clinical Trial (Medical Research Study)
Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Muscle Spasticity |
| Purpose: |
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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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| Study 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,
namely children undergoing selective rhizotomy for treatment of medically refractory
spasticity.
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| 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 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
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| NCT ID: |
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NCT00575536 |
| Primary Contact: |
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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
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| Backup Contact: |
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Email: melba.isom@vanderbilt.edu
Melba T Isom, AS
Phone: 615-875-5853
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| Location Contact: |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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