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

Tracking Information
First Submitted Date	May 26, 2011
First Posted Date	June 2, 2011
Last Update Posted Date	June 2, 2011
Study Start Date	September 2008
Estimated Primary Completion Date	January 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 1, 2011)	DTI MRI findings [ Time Frame: 6 months ]; DTI MRI will be performed before and after radiosurgery to determine if there is a correlation between pain relief, facial numbness, and imaging changes.
Original Primary Outcome Measures	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	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	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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
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.
Condition	Trigeminal Neuralgia
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: June 1, 2011)	50
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	January 2015
Estimated Primary Completion Date	January 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are 1) intolerant of or refractory to medical management and 2) not candidates for or refusing a surgical micro-vascular decompression, will be evaluated for treatment with SRS.; ECOG or Karnofsky Performance Status will not be employed, but patients must be sufficiently healthy to tolerate all study procedures.; Patient must exhibit the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Exclusion criteria; Patients who present with pre-existing facial numbness.; Patients MRI contraindications (e.g., pacemaker or defibrillator, cochlear implant, brain aneurysm clip, etc.); Patients who have previously been treated with MVD.; Patients who have previously had an ablative treatment, including prior SRS.; Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01364272
Other Study ID Numbers	SU-05252011-7807
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Clara Choi, Stanford University School of Medicine
Study Sponsor	Stanford University
Collaborators	Not Provided
Investigators	Principal Investigator: Clara Choi Stanford University Principal Investigator: Scott Soltys Stanford University
PRS Account	Stanford University
Verification Date	May 2011