Clinical Evidence

Neuromodulation: Technology at the Neural Interface, 2026

MUSC - Jeff Borckardt and Xiaolong Peng

Neuromodulation: Technology at the Neural Interface, 2026

MUSC - Jeff Borckardt and Xiaolong Peng

Neuromodulation: Technology at the Neural Interface, 2025

MUSC - Bashar Badran

Trials, 2025

Protocol only paper for tANdem

Bioelectronic Medicine, 2026

Healthy Human Hemostasis

Bioelectronic Medicine, 2026

HMB Pilot 2

Frontiers in Medicine: Obstetrics and Gynecology, 2025

HMB Pilot 1

Bioelectronic Medicine, 2022

Trial to get FDA-clearance for opioid withdrawal

Frontiers in Human Neuroscience: Brain Imaging and Stimulation, 2021

Neonatal Pilot

The purpose of this study is to evaluate the feasibility and preliminary efficacy for transcutaneous auricular neurostimulation (tAN) to improve mood symptoms and decrease climacteric symptoms in women with perimenopause. Participants will use tAN daily for month and complete regular questionnaires weekly. Participants will continue to complete questionnaires for another month without tAN.

The purpose of this study is to evaluate the feasibility and preliminary efficacy for transcutaneous auricular neurostimulation (tAN) reduce the symptoms of PMS/PMDD.

The purpose of this study is to evaluate the feasibility, safety, and preliminary efficacy of transcutaneous auricular neurostimulation (tAN) as a non-invasive therapy for patients with chronic subdural hematomas (cSDH) managed without surgery

The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria).

This open-label, single arm, single-site clinical trial is investigating the safety, feasibility, and preliminary efficacy of transcutaneous auricular neurostimulation to improve outcomes in children with abdominal pain related to disorders of gut-brain interaction. Participants use device for one hour daily over four weeks with a four week follow-up period.

This pilot trial will evaluate the feasibility and acceptability of its procedures and the appropriateness of the tAN intervention for firefighter with Alcohol Use Disorder and Post-Traumatic Stress

This study is designed to test optimal parameters of transcutaneous auricular stimlation (tAN) for the reduction of COWS scores in individuals in precipitated withdrawal. The investigators will evaluate the effects of various tAN stimulation frequencies on NLX-precipitated withdrawal (4mg, intranasal)

This study is a randomized, sham-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of transcutaneous auricular neurostimulation (tAN) using the Sparrow Link device for the reduction of Acute Stress Disorder symptoms following motor vehicle crash. A total of 120 participants will be enrolled and randomized into an active or sham tAN group where participants will use tAN daily for at least one hour for a period of two weeks upon leaving the emergency department. Primary outcome assessments will occur during the first three weeks following MVC, with additional follow-up assessments conducted for an additional nine weeks.

The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.

This study is designed as a prospective, single-arm, decentralized, pilot study evaluating daily transcutaneous auricular neurostimulation (tAN) in first responders with at least mild anxiety. The goal of the study is to test whether daily tAN can improve anxiety, perceived stress, sleep quality, overall well-being, and burnout after one month. The outcomes of this study are measured via standardized patient-reported questionnaires. Enrolled participants use tAN for 28 days (>= 1 hour/day), followed by a 28-day observational follow-up period during which questionnaires continue without active treatment.

The objective of this randomized controlled trial is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures. Blood loss and blood markers will be measured before and during the procedure to measure the effect of the therapy. Surgery time and time to hemostasis will also be measured.