Face mask zaps nerve pain: new hope for trigeminal neuralgia?
NCT ID NCT02708810
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a precise radiation treatment for trigeminal neuralgia, a condition that causes severe facial pain. Instead of a metal frame screwed into the skull, a special face mask holds the head still while x-rays target the painful nerve. The trial includes 40 adults whose pain isn't controlled by medication. Researchers want to see if this frameless approach is feasible and how well it relieves pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Virtual cone radiosurgery device (frameless face mask)
- What this could lead to
- If it works, this could offer a non-invasive, precise treatment option for people with severe facial nerve pain that isn't helped by medication.
- What could go wrong
- This is a small, early-phase trial with only 40 people at one hospital. The device may not relieve pain for everyone, and there are risks of nerve damage or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
40 people
The number who actually took part.
- Started
-
Nov 2015
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 99 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, 35233, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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