Trial record 10 of 20 for:    "Trigeminal neuralgia"

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. (see Contacts and Locations)
Verified May 2011 by Stanford University
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01364272
First received: May 26, 2011
Last updated: June 1, 2011
Last verified: May 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014