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NCT00575536 Clinical Trial

Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures

Spasticity Clinical Trial

— Rhizotomy  

Official title:
Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date April 2018
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Rhizotomy for children with spasticity
Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity

Locations
Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome
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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