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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00575536
First Posted: December 18, 2007
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anita Mahadevan-Jansen, Vanderbilt University
  Purpose
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 Intervention
Spasticity Procedure: Rhizotomy for children with spasticity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases

Further study details as provided by Anita Mahadevan-Jansen, Vanderbilt University:

Primary Outcome Measures:
  • 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

Enrollment: 19
Study Start Date: January 2006
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: December 15, 2007
First Posted: December 18, 2007
Last Update Posted: April 17, 2017
Last Verified: April 2017
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