TENS of Auricular Vagal Nerve for Radiation Necrosis

N/ANot Yet RecruitingNCT07680127

Virginia Commonwealth University40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Radiation Necrosis Cerebral Edema

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

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