Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures

NCT00575536 | Completed

• 1 other identifier: 050822
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity

Keywords

spasticity; rhizotomy; surgery

Outcome Measures

Primary Outcomes (1)

• A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation

  4 hours

Study Arms (1)

Rhizotomy for children with spasticity

Children with spasticity needing Rhizotomy surgery

Procedure: Rhizotomy for children with spasticity

Interventions

Rhizotomy for children with spasticity PROCEDURE

Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity

Rhizotomy for children with spasticity

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children over the age of 3 and younger than 17 years who have failed appropriate medical therapy for spasticity and are recommended for Rhizotomy surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related 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.

  PMID: 26157986 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

abnormal spinal nerves that have been surgically removed

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Rhizotomy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Peter E Konrad, MD, Ph.D.

  Vanderbilt University, Dept. Neurosurgery

  STUDY CHAIR

• Chanqing Kao, MD, Ph.D.

  Vanderbilt University, Dept. Neurosurgery

  PRINCIPAL INVESTIGATOR

• Michael Remple, Ph.D.

  Vanderbilt University, Dept. Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Biomedical Engineering and Neurosurgery

Study Record Dates

• First Submitted: December 15, 2007
• First Posted: December 18, 2007
• Study Start: January 1, 2006
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)