Back to resultsRAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Primary Purpose
Trigeminal Neuralgia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unframed Virtual Cone
80 Gy Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring radiosurgery (RS), trigeminal neuralgia (TGN)
Eligibility Criteria
Inclusion Criteria:
- Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
- Patients must have an ECOG status of 0, 1, or 2
- Patients must be at least 18 years of age
- Life expectancy must be greater than 12 months
- MRI of brain within prior 12 months to confirm lack of other causes of facial pain
- All patients must be given written informed consent
Exclusion Criteria:
- Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
- Patients with atypical trigeminal neuralgia or headache pain syndromes
- Patients with pain associated with multiple sclerosis or base of skull tumor
- Patients with medical contra-indications to MR imaging (e.g. pacemaker)
Sites / Locations
- Hazelrig-Salter Radiation Oncology Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
80 Gy Radiation & Unframed Virtual Cone
Arm Description
80 Gy Virtual Cone Radiosurgery unframed (face mask)
Outcomes
Primary Outcome Measures
Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms.
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".
Secondary Outcome Measures
Number of Participants with treatment-related adverse events
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
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
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?
Full Information
NCT ID
NCT02708810
First Posted
November 16, 2015
Last Updated
March 10, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02708810
Brief Title
RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Official Title
RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2015 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.
Detailed Description
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. To measure pain relief after Virtual Cone radiosurgery utilizing the Barrow Neurologic Institute Pain Intensity Score (BNI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
radiosurgery (RS), trigeminal neuralgia (TGN)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
80 Gy Radiation & Unframed Virtual Cone
Arm Type
Other
Arm Description
80 Gy Virtual Cone Radiosurgery unframed (face mask)
Intervention Type
Device
Intervention Name(s)
Unframed Virtual Cone
Other Intervention Name(s)
Face Mask
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
80 Gy Radiation
Other Intervention Name(s)
Radiosurgery
Primary Outcome Measure Information:
Title
Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
Time Frame
3 Month Follow-Up Visit
Title
The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms.
Description
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".
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Number of Participants with treatment-related adverse events
Description
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.
Time Frame
1 Year
Title
Mean of Quality of Life Scores as measured by SF-36 Questionnaire
Description
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.
Time Frame
1 Year
Title
Patient Satisfaction Scores
Description
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?
Time Frame
3 Month Follow-Up Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
Patients must have an ECOG status of 0, 1, or 2
Patients must be at least 18 years of age
Life expectancy must be greater than 12 months
MRI of brain within prior 12 months to confirm lack of other causes of facial pain
All patients must be given written informed consent
Exclusion Criteria:
Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
Patients with atypical trigeminal neuralgia or headache pain syndromes
Patients with pain associated with multiple sclerosis or base of skull tumor
Patients with medical contra-indications to MR imaging (e.g. pacemaker)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fiveash, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hazelrig-Salter Radiation Oncology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
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