Clinical trials: Transcutaneous Vagus Nerve Stimulation
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.
Epilepsy
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
- Trial name
- NCT01178437
- Testing
- T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- cerbomed GmbH
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.
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
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear.
- Trial name
- NCT01176734
- Testing
- tVNS-Device
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- cerbomed GmbH
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.
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.
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.
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
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.
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.
Schizophrenia
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.
- Trial name
- 02VNS2009 (NCT01176721)
- Testing
- t-VNS verum
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- cerbomed GmbH
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
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.
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.
Pain
Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System
The increased incidence of pain syndromes requires the investigation of pathophysiological coherences as well as searching for new therapies.
- Trial name
- NCT01174498
- Testing
- Cerbomed t-VNS® transcutaneous stimulation
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- cerbomed GmbH