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

Trigeminal Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364272
• Other study ID #: SU-05252011-7807
• Secondary ID: IRB 15136
• Status: Completed
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DTI MRI findings	DTI MRI will be performed before and after radiosurgery to determine if there is a correlation between pain relief, facial numbness, and imaging changes.	6 months