Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures

• Sponsor: Vanderbilt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00575536
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Duration (Months): 142
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spasticity	Procedure: Rhizotomy for children with spasticity

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 19 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Rhizotomy for children with spasticity Children with spasticity needing Rhizotomy surgery	Procedure: Rhizotomy for children with spasticity; Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity

Outcome Measures

Primary Outcome Measures

1. A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation [4 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University

Investigators

• Study Chair: Peter E Konrad, MD, Ph.D., Vanderbilt University, Dept. Neurosurgery
• Principal Investigator: Chanqing Kao, MD, Ph.D., Vanderbilt University, Dept. Neurosurgery
• Principal Investigator: Michael Remple, Ph.D., Vanderbilt University, Dept. Neurosurgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anita Mahadevan-Jansen, Professor Biomedical Engineering and Neurosurgery, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT00575536
• Other Study ID Numbers: 050822
• First Posted: Dec 18, 2007
• Last Update Posted: May 1, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Keywords provided by Anita Mahadevan-Jansen, Professor Biomedical Engineering and Neurosurgery, Vanderbilt University: spasticity; rhizotomy; surgery
• Additional relevant MeSH terms: Muscle Spasticity

Study Results

No Results Posted as of May 1, 2018