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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ClinicalTrials.gov Identifier: NCT01364272 |
Recruitment Status : Unknown
Verified May 2011 by Stanford University.
Recruitment status was: Recruiting
First Posted : June 2, 2011
Last Update Posted : June 2, 2011
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Condition or disease |
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Trigeminal Neuralgia |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Study Start Date : | September 2008 |
Estimated Primary Completion Date : | January 2015 |
Estimated Study Completion Date : | January 2015 |

- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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): NCT01364272
Contact: Lisa Jacobs | (650) 723-8843 | ljacobs@stanford.edu |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Lisa Jacobs 650-723-8843 ljacobs@stanford.edu | |
Principal Investigator: Scott Soltys | |
Principal Investigator: Clara Choi |
Principal Investigator: | Clara Choi | Stanford University | |
Principal Investigator: | Scott Soltys | Stanford University |
Responsible Party: | Clara Choi, Stanford University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01364272 |
Other Study ID Numbers: |
SU-05252011-7807 |
First Posted: | June 2, 2011 Key Record Dates |
Last Update Posted: | June 2, 2011 |
Last Verified: | May 2011 |
Trigeminal Neuralgia Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations |
Trigeminal Nerve Diseases Facial Neuralgia Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases |