Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01364285
First received: May 26, 2011
Last updated: June 1, 2011
Last verified: May 2011
History of Changes
  Purpose

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
Trigeminal Neuralgia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Patient Reported Outcomes After Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Patient satisfaction following CyberKnife radiosurgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To assess patient reported outcomes following stereotactic radiosurgical rhizotomy for trigeminal neuralgia.


Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (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 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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
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 May 16, 2013