SpasticityRhizotomyNCT00575536
Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures
An observational study of Spasticity, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Spasticity
- What is being tested?
- Rhizotomy for children with spasticity
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases
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.
Read the 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.
- Conditions
- Spasticity
- Being tested
- Rhizotomy for children with spasticity
- Keywords
- spasticity, rhizotomy, surgery
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhizotomy for children with spasticityProcedure or surgery
Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity
| Study group | Role | What they receive |
|---|---|---|
| Rhizotomy for children with spasticity | Children with spasticity needing Rhizotomy surgery Receives: Procedure: Rhizotomy for children with spasticity |
What is being measured
The primary outcome is the main question the study is designed to answer.
A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Mahadevan-Jansen, Vanderbilt University
- Investigators
- Peter E Konrad, MD, Ph.D., Study chair, Vanderbilt University, Dept. NeurosurgeryChanqing Kao, MD, Ph.D., Principal investigator, Vanderbilt University, Dept. NeurosurgeryMichael Remple, Ph.D., Principal investigator, Vanderbilt University, Dept. Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575536
- Sponsor's protocol ID
- 050822
- Acronym
- Rhizotomy
- Status last verified
- Apr 2018
- First submitted
- 15 Dec 2007
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
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.
PubMed 26157986
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases
- ClinicalTrials.gov ID
- NCT00575536
- Acronym / sponsor ID
- Rhizotomy / 050822
- Conditions
- Spasticity
- Keywords
- spasticity, rhizotomy, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rhizotomy for children with spasticity | – | Procedure: Rhizotomy for children with spasticityChildren with spasticity needing Rhizotomy surgery |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhizotomy for children with spasticityOptical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity | Procedure or surgery | Rhizotomy for children with spasticity |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Results publication: PubMed 26157986Cayce 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter E Konrad, MD, Ph.D. study chair
Vanderbilt University, Dept. Neurosurgery
Chanqing Kao, MD, Ph.D. principal investigator
Vanderbilt University, Dept. Neurosurgery
Michael Remple, Ph.D. principal investigator
Vanderbilt University, Dept. Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00575536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.