Clinical trials: Auricular Vagus Nerve Stimulation
Blood Loss, Surgical
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
- Trial name
- NCT06647017
- Testing
- Volta tAN System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University Surgical Vascular
Autism Spectrum Disorder
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder
Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder
- Trial name
- NCT06473623
- Testing
- vagus nerve stimulation
- Where
- Hong Kong
- Volunteers
- 20 people
- Sponsor
- Neuropix
Rheumatoid Arthritis (RA)
Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis - the TRAVAGA Study
Purpose and aim The overall aim is to investigate efficacy and safety of a newly developed non-invasive auricular investigational device that electrically stimulates the auricular branch of the vagus nerve to activate the…
- Trial name
- TRAVAGA (NCT06779123)
- Testing
- Transauricular vagus nerve stimulation., transauricular vagus nerve non-stimulation
- Where
- 6 sites in Sweden
- Volunteers
- 128 people
- Sponsor
- taVNS AB
Opioid-use Disorder, Opioid Withdrawal
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
- Trial name
- RESTORE (NCT05053503)
- Testing
- Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- Spark Biomedical, Inc.
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
Opioid-use Disorder, Opioid Withdrawal
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate…
- Trial name
- NCT04075214
- Testing
- transcutaneous auricular neurostimulation (tAN)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Spark Biomedical, Inc.
Opioid-use Disorder, Opioid Withdrawal
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
- Trial name
- NCT04731935
- Testing
- Sparrow Therapy System
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Spark Biomedical, Inc.
Vascular Dementia, Mild Cognitive Impairment
Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
This clinical trial evaluates the preliminary effectiveness and safety of Cerogrin, a medical device developed by Neurogrin Inc.
- Trial name
- NCT07149038
- Testing
- Cerogrin
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Neurogrin Inc.
Acute Stress Reaction, Cognitive Performance
Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.
- Trial name
- ASR (NCT06390267)
- Testing
- Sparrow Hawk (Active)
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Spark Biomedical, Inc.
Mental Fatigue, Mental Stress
tAN for First Responders
This study is designed as an open label, single arm, decentralized clinical study in which first responders will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve…
- Trial name
- NCT07109349
- Testing
- Sparrow Link
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Spark Biomedical, Inc.
Hemostasis, Blood Biomarkers
Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus…
- Trial name
- HHS (NCT05977946)
- Testing
- Volta System
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Spark Biomedical, Inc.
Tinnitus, Subjective Tinnitus
Efficacy and Safety of the Soricle for Subjective Tinnitus Relief
This study was conducted to evaluate the efficacy and safety of Soricle, a medical device combining transcutaneous vagus nerve stimulation and sound stimulation, in patients with subjective tinnitus.
- Trial name
- NCT07548320
- Testing
- tVNS Device, tVNS + Sound Stimulation Device
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Neurive Co.,Ltd.
Chronic Low Back Pain (CLBP)
SENECA - Smart Therapies for Chronic Pain
This will be a randomized controlled prospective pilot study: The feasibility and usability of VIVO 2nd GEN therapy + Standard-of-Care (SoC) vs. Standard-of-Care alone will be evaluated.
- Trial name
- SENECA (NCT07628179)
- Testing
- VIVO 2nd GEN, Standard-of-Care Multimodal Pain Therapy
- Where
- Austria
- Volunteers
- 44 people
- Sponsor
- Aurimod GmbH
Alcohol Use Disorder, Alcohol Abuse
tAN for Substance Use Disorder
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).
- Conditions
- Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State
- Trial name
- NCT07281261
- Testing
- Sparrow Ascent
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Spark Biomedical, Inc.
Von Willebrand Disease, Type 1, Heavy Menstrual Bleeding
Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease
The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease…
- Trial name
- VWD/HMB (NCT06064851)
- Testing
- Volta System
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Five Liters, Inc.
Chronic Low-back Pain
Personalized Auricular Vagus Nerve Stimulation in Intractable Chronic Low Back Pain
One in five people in the general adult population suffer from chronic pain, a figure that is higher than heart disease, cancer, and diabetes combined. A majority of these patients is suffering from chronic back pain.
- Trial name
- AuriMod (NCT04753528)
- Testing
- AuriMod CT01_A, AuriMod CT01_B, AuriMod CT01_C
- Where
- 2 sites in Austria, Switzerland
- Volunteers
- 43 people
- Sponsor
- Aurimod GmbH
Duchenne Muscular Dystrophy (DMD)
Can External Vagus Nerve Stimulation Reduce Systemic Levels of Inflammatory Mediators in Duchenne Muscular Dystrophy Patients?
The intended investigation is a pilot study to evaluate the safety and efficacy of a novel transcutaneous auricular vagus nerve stimulator system, termed TRAVAGUS ONE, to reduce systemic levels of inflammatory mediators in…
- Trial name
- Travagus One (NCT07543302)
- Testing
- Transcutaneous auricular vagus nerve stimulation
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- taVNS AB
Heavy Menstrual Bleeding
Delivering tAN to Reduce HMB: The LUNA Study
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.
- Trial name
- LUNA (NCT07326722)
- Testing
- Sparrow Link
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Spark Biomedical, Inc.
Alcohol Use Disorder
A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear
Alcohol Use Disorders (AUD's) are a major health and social problem. Relapse is a rule rather than an exception in alcohol dependence, leading to poor outcomes. Craving are frequently associated with relapse.
- Trial name
- NCT04106739
- Testing
- Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS)
- Where
- India
- Volunteers
- 44 people
- Sponsor
- DyAnsys, Inc.