Radiation NecrosisNCT07680127
TENS of Auricular Vagal Nerve for Radiation Necrosis
A study testing Transcutaneous auricular vagal nerve stimulation (taVNS) in people with Radiation Necrosis and Cerebral Edema, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This is a multi-center, randomized, blinded trial evaluating the effect of transcutaneous auricular vagal nerve stimulator (taVNS) on radiation necrosis-related cerebral edema. In this study, consenting and eligible patients will be assigned to one of two arms: treatment (Arm 1) or sham (Arm 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Necrosis, Cerebral Edema
- What is being tested?
- Transcutaneous auricular vagal nerve stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 Aug 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
Amy Erickson, 804-828-9165, amy.erickson@vcuhealth.org
Ryan Cleary, MD
About this study
Official title: Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis
This is a multi-center, randomized, blinded trial evaluating the effect of transcutaneous auricular vagal nerve stimulator (taVNS) on radiation necrosis-related cerebral edema. In this study, consenting and eligible patients will be assigned to one of two arms: treatment (Arm 1) or sham (Arm 2). Patients in both arms will have imaging performed and tissue and blood collected for assessment of changes in area of contrast enhancement and cerebral edema, inflammatory markers, and markers of blood-brain barrier permeability.
- Conditions
- Radiation Necrosis, Cerebral Edema
- Being tested
- Transcutaneous auricular vagal nerve stimulation (taVNS), Sham
- Keywords
- Radiation Necrosis
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagal nerve stimulation (taVNS)Device
Transcutaneous auricular vagal nerve stimulation (taVNS) stimulation twice daily for 12 to 14 days prior to planned LITT ablation via TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear.
ShamDevice
TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear, with no stimulation twice daily for 12 to 14 days prior to planned LITT ablation.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) | Experimental | Not described Receives: Device: Transcutaneous auricular vagal nerve stimulation (taVNS) |
| Sham | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
Percent change in serum inflammatory marker TNF-alpha utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Secondary outcomes (18)
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
Percent change in (IL-12) serum inflammatory marker utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)
Percent change in serum inflammatory marker GMCSF utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)
Percent change in serum inflammatory marker IFN gamma utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b)
Percent change in serum inflammatory marker IL-1b utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin-10 (IL-10)
Percent change in serum inflammatory marker IL-10 utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 13 (IL-13)
Percent change in serum inflammatory marker IL-13 utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin (IL-2)
Percent change in serum inflammatory marker IL-2 utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory markers interleukin 17 (IL-17A)
Percent change in serum inflammatory markers IL-17A utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 4 (IL-4)
Percent change in serum inflammatory marker IL-4 utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 5 (IL-5)
Percent change in serum inflammatory markers IL-5 utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 6 (IL-6)
Percent change in serum inflammatory markers IL-6 utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 8 (IL-8)
Percent change in serum inflammatory markers IL-8 utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, 1 week, and 2 weeks following intervention
Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment
Percent change of NFL marker of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, and 2 weeks following intervention
Assess changes in biomarker platelet-derived growth factor receptor-beta (PDGFR-beta) of central nervous system (CNS) injury following treatment
Percent change of marker PDGFR-beta of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, and 2 weeks following intervention
Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment
Percent change of marker VEGF of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
Measured: Baseline, and 2 weeks following intervention
Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment
Percent change of BBB permeability
Measured: Baseline, and 2 weeks following intervention
Assess interval changes in radiation necrosis on MRI after treatment w taVNS
Percent changes in areas of contrast enhancement and perilesional T2-weighted fluid-attenuated inversion recovery (T2/FLAIR) Hypersensitivity on magnetic resonance imaging (MRI). On these images, areas with higher water content suck as edema, inflammation, or demyelination, appear brighter compared to surrounding tissue.
Measured: Baseline, and 2 weeks following intervention
Assess interval changes in cerebral edema on MRI after treatment
Percent changes in areas of contrast enhancement and perilesional T2/FLAIR Hypersensitivity on MRI
Measured: Baseline, and 2 weeks following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation NecrosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Cleary, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680127
- Sponsor's protocol ID
- MCC-25-22821
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis
- ClinicalTrials.gov ID
- NCT07680127
- Acronym / sponsor ID
- MCC-25-22821
- Conditions
- Radiation Necrosis, Cerebral Edema
- Keywords
- Radiation Necrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 2 Jul 2026 (actual)
- 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.
This is a multi-center, randomized, blinded trial evaluating the effect of transcutaneous auricular vagal nerve stimulator (taVNS) on radiation necrosis-related cerebral edema. In this study, consenting and eligible patients will be assigned to one of two arms: treatment (Arm 1) or sham (Arm 2). Patients in both arms will have imaging performed and tissue and blood collected for assessment of changes in area of contrast enhancement and cerebral edema, inflammatory markers, and markers of blood-brain barrier permeability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) | Experimental | Device: Transcutaneous auricular vagal nerve stimulation (taVNS) |
| Sham | Sham comparator | Device: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Transcutaneous auricular vagal nerve stimulation (taVNS)Transcutaneous auricular vagal nerve stimulation (taVNS) stimulation twice daily for 12 to 14 days prior to planned LITT ablation via TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear. | Device | Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) |
| ShamTENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear, with no stimulation twice daily for 12 to 14 days prior to planned LITT ablation. | Device | Sham |
Primary outcome
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
Time frame: Baseline, 1 week, and 2 weeks following intervention
Percent change in serum inflammatory marker TNF-alpha utilizing serum inflammatory marker analysis from collected blood samples
18 secondary outcomes
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin-10 (IL-10)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 13 (IL-13)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin (IL-2)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory markers interleukin 17 (IL-17A)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 4 (IL-4)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 5 (IL-5)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 6 (IL-6)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 8 (IL-8)
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment
Time frame: Baseline, and 2 weeks following intervention
Assess changes in biomarker platelet-derived growth factor receptor-beta (PDGFR-beta) of central nervous system (CNS) injury following treatment
Time frame: Baseline, and 2 weeks following intervention
Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment
Time frame: Baseline, and 2 weeks following intervention
Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment
Time frame: Baseline, and 2 weeks following intervention
Assess interval changes in radiation necrosis on MRI after treatment w taVNS
Time frame: Baseline, and 2 weeks following intervention
Assess interval changes in cerebral edema on MRI after treatment
Time frame: Baseline, and 2 weeks following intervention
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 4 Sep 2026.
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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.
Ryan Cleary, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular vagal nerve stimulation (taVNS) in people with Radiation Necrosis and Cerebral Edema, run by Virginia Commonwealth University 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
Contact Amy Erickson (804-828-9165, amy.erickson@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha (time frame: Baseline, 1 week, and 2 weeks following intervention). 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 4 Sep 2026.