Trigeminal NeuralgiaNCT02708810
RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
A study testing Unframed Virtual Cone and 80 Gy Radiation in people with Trigeminal Neuralgia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Unframed Virtual Cone and 80 Gy Radiation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, 35233
About this study
Official title: RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.
Read the 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).
- Conditions
- Trigeminal Neuralgia
- Being tested
- Unframed Virtual Cone, 80 Gy Radiation
- Keywords
- radiosurgery (RS), trigeminal neuralgia (TGN)
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unframed Virtual ConeDevice
Also called Face Mask
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.
80 Gy RadiationRadiation
Also called Radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| 80 Gy Radiation & Unframed Virtual Cone | Other | 80 Gy Virtual Cone Radiosurgery unframed (face mask) Receives: Device: Unframed Virtual Cone; Radiation: 80 Gy Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
Measured: 3 Month Follow-Up Visit
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".
Measured: 1 Year
Secondary outcomes (3)
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.
Measured: 1 Year
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.
Measured: 1 Year
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?
Measured: 3 Month Follow-Up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startNov 2015
- Primary completion1 Oct 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Fiveash, MD, University of Alabama at Birmingham
- Investigators
- John Fiveash, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708810
- Sponsor's protocol ID
- IRB-150608005
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2015
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
- ClinicalTrials.gov ID
- NCT02708810
- Acronym / sponsor ID
- IRB-150608005
- Conditions
- Trigeminal Neuralgia
- Keywords
- radiosurgery (RS), trigeminal neuralgia (TGN)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 80 Gy Radiation & Unframed Virtual Cone | Other | Device: Unframed Virtual Cone, Radiation: 80 Gy Radiation80 Gy Virtual Cone Radiosurgery unframed (face mask) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unframed Virtual ConeAlso: Face MaskA 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. | Device | 80 Gy Radiation & Unframed Virtual Cone |
| 80 Gy RadiationAlso: Radiosurgery | Radiation | 80 Gy Radiation & Unframed Virtual Cone |
Primary outcome
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".
3 secondary outcomes
Number of Participants with treatment-related adverse events
Time frame: 1 Year
Mean of Quality of Life Scores as measured by SF-36 Questionnaire
Time frame: 1 Year
Patient Satisfaction Scores
Time frame: 3 Month Follow-Up Visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Fiveash, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unframed Virtual Cone and 80 Gy Radiation in people with Trigeminal Neuralgia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.