Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
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| First Received Date ICMJE | May 26, 2011 | ||||||||
| Last Updated Date | June 1, 2011 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
DTI MRI findings [ Time Frame: 6 months ] [ Designated as safety issue: No ] DTI MRI will be performed before and after radiosurgery to determine if there is a correlation between pain relief, facial numbness, and imaging changes. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01364272 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia | ||||||||
| Official Title ICMJE | Investigation of Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia | ||||||||
| Brief Summary | Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. To better understand how radiosurgery can bring about pain relief and facial numbness, we are conducting a study in which brain MRI scans will be done following stereotactic radiosurgery to learn if there are any changes in the MRI scans that correlate with symptoms. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who was treated with SRS. |
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| Condition ICMJE | Trigeminal Neuralgia | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | January 2015 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01364272 | ||||||||
| Other Study ID Numbers ICMJE | SU-05252011-7807 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Clara Choi, Stanford University School of Medicine | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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