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 Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Trigeminal Neuralgia

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Clara Choi, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT01364272 History of Changes
Other Study ID Numbers:	SU-05252011-7807
First Posted:	June 2, 2011
Last Update Posted:	June 2, 2011
Last Verified:	May 2011

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; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases