RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02708810|
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuralgia||Device: Unframed Virtual Cone Radiation: 80 Gy Radiation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2021|
80 Gy Radiation & Unframed Virtual Cone
80 Gy Virtual Cone Radiosurgery unframed (face mask)
Device: Unframed Virtual Cone
A face mask (unframed) will be placed over the patient's face to keep their head from moving during the procedure. This will allow for very precise targeting. During the procedure, the study doctor will also confirm the exact location that needs to be treated using x-rays and optical imaging cameras. The face mask (unframed) will hold the patient's head to prevent it from moving and to focus the x-rays and aim them on the painful nerve in the patient's brain. For most patients, the actual time on the radiosurgery treatment machine is in the range of 30 to 60 minutes. The face mask (unframed) will be removed after the treatment.
Other Name: Face Mask
Radiation: 80 Gy Radiation
Other Name: Radiosurgery
- Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment [ Time Frame: 3 Month Follow-Up Visit ]
- The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms. [ Time Frame: 1 Year ]Pain Relief Score designed to assess trigeminal neuralgia associated pain. It ranges from "I" being "no trigeminal pain, no medication" to "V" being "severe pain/no pain relief".
- Number of Participants with treatment-related adverse events [ Time Frame: 1 Year ]Based on the assessments of the patient and the responses provided by the patient in questionnaires, we will assess acute and late neurologic toxicities. All adverse events/toxicities will be assessed with the utilization of CTCAE v.4.0.
- Mean of Quality of Life Scores as measured by SF-36 Questionnaire [ Time Frame: 1 Year ]Quality of Life (QOL) will be measured by SF-36. This questionnaire consists of 36 questions (items) measuring physical and mental health in relation to 8 health concepts: physical functioning, bodily pain, role of limitations due to physical health problems, role of limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perception. All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively.
- Patient Satisfaction Scores [ Time Frame: 3 Month Follow-Up Visit ]3 months following the completion of radiosurgery, the patient will be asked the following two questions: 1) Would you have the radiosurgery procedure again? 2) Would you recommend it to friends and family?
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): NCT02708810
|Contact: Kristin K. Webbemail@example.com|
|United States, Alabama|
|Hazelrig-Salter Radiation Oncology Center||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||John Fiveash, MD||University of Alabama at Birmingham|