TENS of Auricular Vagal Nerve for Radiation Necrosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcutaneous auricular vagal nerve stimulation (taVNS)
- Sham
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
1Virginia Commonwealth University23298, RichmondVirginia, United States
Sponsors and collaborators
Virginia Commonwealth University
Lead sponsor
Source ClinicalTrials.gov