Spasticity Clinical Trial
— RhizotomyOfficial title:
Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases
NCT number | NCT00575536 |
Other study ID # | 050822 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2006 |
Est. completion date | November 2017 |
Verified date | April 2018 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Cayce JM, Wells JD, Malphrus JD, Kao C, Thomsen S, Tulipan NB, Konrad PE, Jansen ED, Mahadevan-Jansen A. Infrared neural stimulation of human spinal nerve roots in vivo. Neurophotonics. 2015 Jan;2(1):015007. doi: 10.1117/1.NPh.2.1.015007. Epub 2015 Feb 23 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation | 4 hours |
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