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Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures (Rhizotomy)

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ClinicalTrials.gov Identifier: NCT00575536
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Anita Mahadevan-Jansen, Vanderbilt University

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
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 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 : January 2006
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Group/Cohort 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




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 [ Time Frame: 4 hours ]

Biospecimen Retention:   Samples Without DNA
abnormal spinal nerves that have been surgically removed


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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575536


Locations
United States, Tennessee
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

Publications of Results:
Responsible Party: Anita Mahadevan-Jansen, Professor Biomedical Engineering and Neurosurgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00575536     History of Changes
Other Study ID Numbers: 050822
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Anita Mahadevan-Jansen, Vanderbilt University:
spasticity
rhizotomy
surgery

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms