ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Patient Reported Outcomes After Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01364285
Recruitment Status : Unknown
Verified May 2011 by Stanford University.
Recruitment status was:  Recruiting
First Posted : June 2, 2011
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
Stanford University

Brief Summary:
The investigators know little about how patients feel following radiosurgery treatment of trigeminal neuralgia. Patient satisfaction may ultimately be one of the most important outcome measures for an individual patient; however, this has not been adequately assessed or followed. Multiple questions remain unanswered, including whether there is a correlation between patient satisfaction, the level of their current pain score, and the presence and degree of facial numbness, a possible side effect after radiosurgery. Therefore, the goal of this study is to gather this information from the patients who received radiosurgery for trigeminal neuralgia at Stanford and evaluate post-treatment patient satisfaction, the degree of facial numbness, and current pain score. This data will help the investigators understand outcomes that are important for patient satisfaction following treatment of a chronic pain syndrome.

Condition or disease
Trigeminal Neuralgia

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Patient Reported Outcomes After Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
Study Start Date : May 2009
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Patient satisfaction following CyberKnife radiosurgery [ Time Frame: 1 year ]
    To assess patient reported outcomes following stereotactic radiosurgical rhizotomy for trigeminal neuralgia.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 of the patients since 2000 who have undergone stereotactic radiosurgical rhizotomy at Stanford for treatment of trigeminal neuralgia.
Criteria

Inclusion Criteria:

  • All of the patients since 2000 who have undergone stereotactic radiosurgical rhizotomy at Stanford for treatment of trigeminal neuralgia.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364285


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

Responsible Party: Clara Choi, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01364285     History of Changes
Other Study ID Numbers: SU-05252011-7808
IRB 16883
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Trigeminal Neuralgia
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