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

• ClinicalTrials.gov Identifier: NCT01364272
• Recruitment Status: Completed
• First Posted: June 2, 2011
• Last Update Posted: October 28, 2021
• Sponsor: Stanford University
• Information provided by (Responsible Party): Scott Soltys, Stanford University

Study Description

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

• Study Type: Observational
• Actual Enrollment: 1 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
• Actual Study Start Date: September 2008
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: September 2010

Groups and Cohorts

Outcome Measures

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

• 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

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

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Clara Choi; Stanford University
• Principal Investigator: Scott Soltys; Stanford University

More Information

• Responsible Party: Scott Soltys, Associate Professor of Radiation Oncology, Stanford University
• ClinicalTrials.gov Identifier: NCT01364272
• Other Study ID Numbers: SU-05252011-7807; IRB 15136 ( Other Identifier: Stanford IRB )
• First Posted: June 2, 2011
• Last Update Posted: October 28, 2021
• Last Verified: October 2021

Additional relevant MeSH terms:

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