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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

NCT ID: NCT01364272

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Trigeminal Neuralgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Scott Soltys

Associate Professor of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clara Choi

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Scott Soltys

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 15136

Identifier Type: OTHER

Identifier Source: secondary_id

SU-05252011-7807

Identifier Type: -

Identifier Source: org_study_id