TENS of Auricular Vagal Nerve for Radiation Necrosis

ConditionsRadiation Necrosis Cerebral Edema

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

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.
Sham
Device
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)Experimental treatment 1 intervention

Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame