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
This study is currently recruiting participants.
Verified May 2011 by Stanford University
Sponsor:
Stanford University
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01364272
First received: May 26, 2011
Last updated: June 1, 2011
Last verified: May 2011
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Purpose
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.
| Condition |
|---|
|
Trigeminal Neuralgia |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364272
Contacts
| Contact: Lisa Jacobs | (650) 723-8843 | ljacobs@stanford.edu |
Locations
| 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 | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Clara Choi | Stanford University |
| Principal Investigator: | Scott Soltys | Stanford University |
More Information
No publications provided
| Responsible Party: | Clara Choi, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01364272 History of Changes |
| Other Study ID Numbers: | SU-05252011-7807 |
| Study First Received: | May 26, 2011 |
| Last Updated: | June 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neuralgia Trigeminal Neuralgia Pain Neurologic Manifestations Nervous System Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Trigeminal Nerve Diseases Cranial Nerve Diseases |
ClinicalTrials.gov processed this record on May 16, 2013