Earpiece zaps nerves to shrink Radiation-Damaged brain swelling
NCT ID NCT07680127
First seen Jul 02, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests whether a gentle electrical earpiece, worn twice daily for two weeks, can reduce brain swelling caused by radiation necrosis. The device stimulates a nerve in the ear to calm inflammation. Forty people with brain tumors who need a laser procedure will be randomly assigned to receive real or sham stimulation, and researchers will measure changes in swelling and inflammatory markers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous auricular vagal nerve stimulation (taVNS) device
- What this could lead to
- If effective, this non-invasive earpiece could offer a new way to reduce brain swelling after radiation therapy, potentially reducing the need for steroids or surgery.
- What could go wrong
- This is an early-stage trial with only 40 participants, so results may not apply broadly. The treatment is short-term and may not produce lasting benefits.
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
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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
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * History of glioma or metastatic brain lesion previously treated with whole brain radiation, stereotactic radiation surgery, or fractionated radiation therapy * Magnetic resonance imaging (MRI) findings consistent with possible radiation necrosis within 6 weeks prior to enrollment. * Candidate for tissue biopsy and Laser Interstitial Thermal Therapy (LITT) ablation of the lesion * At least 18 years of age * If on corticosteroids, able to discontinue at least 5 days prior to start of transcutaneous auricular vagus nerve stimulation (taVNS) (Arm 1) or sham treatment (Arm 2). A stable physiologic dose of corticosteroids, if used as hormone replacement therapy, may be allowed upon discussion with the investigator. 6. Ability to understand and willingness to sign an institutional review board (IRB) approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: * New onset neurologic deficits secondary to radiation necrosis requiring initiation of dexamethasone therapy or other intervention prior to enrollment * Currently receiving bevacizumab for treatment of radiation necrosis or has received bevacizumab \< 6 weeks prior to study enrollment. * Currently receiving any investigational agents for treatment of radiation necrosis or has participated in a study of an investigational agent for radiation necrosis within 3 weeks prior to study enrollment. * History of cardiac conduction disorders or presence of implanted electronic devices * Active Crohn's disease or other inflammatory bowel disease. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Virginia Commonwealth University
Richmond, Virginia, 23298, United States
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