Clinical trials: Vagus Nerve Stimulations
Heart Failure, Congestive Heart Failure
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and…
- Trial name
- NECTAR-HF (NCT01385176)
- Testing
- Implant of investigational device system, Titration during the randomization phase, Titration after the randomization phase
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 118 people
- Sponsor
- Boston Scientific Corporation
Major Depressive Disorder
Vagal Nerve Stimulation for Treatment Resistant Major Depression
The purpose of this study is to 1) explore whether vagal nerve stimulation (nVNS) using a hand- held non-invasive device (gammaCore™) works to treat depression and 2) to confirm gammaCore™'s safety profile.
- Trial name
- NCT04990687
- Testing
- gammaCore™
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Alabama at Birmingham
Functional Gastrointestinal Disorders, Vagus Nerve Autonomic Disorder
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by…
- Conditions
- Functional Gastrointestinal Disorders, Vagus Nerve Autonomic Disorder, Irritable Bowel Syndrome, Nausea
- Trial name
- NCT04247100
- Testing
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Gisela Grotewold Chelimsky
COVID, Corona Virus Infection
Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care…
- Conditions
- COVID, Corona Virus Infection, Respiratory Failure, Respiratory Distress Syndrome, Adult
- Trial name
- SAVIORII (NCT04382391)
- Testing
- gammaCore® Sapphire (non-invasive vagus nerve stimulator), Standard of care therapies
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Poor Feeding, Infant Development
taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds
Oromotor dysfunction and poor feeding is common after premature birth and hypoxic ischemic encephalopathy (HIE). Pairing vagus nerve stimulation (VNS) with motor activity accelerates functional improvements after stroke.
- Conditions
- Poor Feeding, Infant Development, Vagus Nerve Stimulation
- Trial name
- NCT04643808
- Testing
- transcutaneous auricular vagus nerve stimulation
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Medical University of South Carolina
Pain, Migraine
Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness
The researchers propose studying Gulf veterans with Gulf War Illness (GWI), characterized by a problem with widespread pain. Besides their pain, the researchers will also assess the effect of vagus nerve stimulation (VNS) in…
- Trial name
- NCT02791893
- Testing
- VNS device, Inactive device
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Benjamin Natelson
Epilepsy, Seizures
Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned VNS Therapy dose settings in patients with…
- Trial name
- ASCEND (NCT02385526)
- Testing
- Vagus Nerve Stimulation Therapy
- Where
- 15 sites in United States
- Volunteers
- 67 people
- Sponsor
- Cyberonics, Inc.
Epilepsy
Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures
This is a randomized study designed to compare long-term treatment outcomes in pediatric patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus anti-epileptic drugs (AEDs).
- Trial name
- NCT01118455
- Testing
- Vagus Nerve Stimulation (VNS) Therapy, Anti-Epileptic Drug (AED)
- Where
- 19 sites in Austria, Belgium and 3 more
- Volunteers
- 134 people
- Sponsor
- Cyberonics, Inc.
Acute Respiratory Distress Syndrome, Acute Lung Injury
Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress
This is a prospective, randomized, two-arm, controlled 30-day investigational pilot trial using the gammaCore Sapphire S non-invasive vagus nerve stimulation (nVNS) device + standard of care (SOC) in newly-hospitalized patients…
- Conditions
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Traumatic Brain Injury
- Trial name
- NCT04935697
- Testing
- nVNS, SOC
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Seizure
Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy
The purpose of this study is to see the effects of non-invasive vagal nerve stimulation for the reduction in frequency of seizure associated with epilepsy in subjects 18 or older.
- Trial name
- NCT01910129
- Testing
- gammaCore
- Where
- 2 sites in Australia
- Volunteers
- 13 people
- Sponsor
- ElectroCore INC
Crohn Disease
Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study
To assess the safety and efficacy of transcutaneous vagal stimulation in adult patients with active Crohn's disease.
- Trial name
- VNS (NCT05165108)
- Testing
- Vagal Nerve Stimulator
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Atrial Fibrillation, Inflammation
Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation
Atrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at voltages substantially below that which slowed the…
- Trial name
- TREAT-AF (NCT02548754)
- Testing
- Parasym device
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of Oklahoma
Vagus Nerve Stimulation
Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding
This study aims to understand the role of the vagus nerve in promoting social bonding by using a non-invasive stimulation technique called transcutaneous vagal nerve stimulation (tVNS).
- Trial name
- CtVNS (NCT05899413)
- Testing
- Transcutaneous vagal nerve stimulation
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Delirium
TaVNS for Delirium
The goal of this clinical trial is to test whether a non-invasive device called transauricular vagus nerve stimulation (taVNS) is safe, practical, and potentially helpful for patients in the hospital who develop delirium.
- Trial name
- NCT07258082
- Testing
- Transauricular Vagus Nerve Stimulation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stony Brook University
Raynaud Phenomenon, Primary Raynaud Phenomenon
Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena.
Raynaud's phenomenon (RP) is a common vascular disorder that affects approximately 10% of the general population. RP is associated with significant morbidity that may include loss of the digits due to repeated episodes of…
- Conditions
- Raynaud Phenomenon, Primary Raynaud Phenomenon, Raynaud Disease, Raynaud Syndrome
- Trial name
- NCT03869008
- Testing
- gammaCore Sapphire
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of Toledo Health Science Campus
Cluster Headache
Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache.
- Trial name
- CH (NCT01792817)
- Testing
- GammaCore
- Where
- 20 sites in United States
- Volunteers
- 150 people
- Sponsor
- ElectroCore INC
Stroke, Upper Limb Deficits
VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke
The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures…
- Trial name
- NCT02243020
- Testing
- Vagus Nerve Stimulation (VNS)
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- MicroTransponder Inc.
Infant of Diabetic Mother, Oxidative Stress
NAC +taVNS in IDM Who Are Poor Oral Feeders
Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired…
- Conditions
- Infant of Diabetic Mother, Oxidative Stress, Vagus Nerve Stimulation, Feeding Disorders
- Trial name
- NCT04632069
- Testing
- N acetyl cysteine + vagus nerve stimulation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medical University of South Carolina
PostTraumatic Stress Disorder
Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder
The tasks of the project are to map the potency and kinetics of the neurologic, autonomic peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs.
- Trial name
- NCT02992899
- Testing
- GammaCore/electroCore non-invasive VNS device, O-15 water
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Emory University
Migraine
Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.
- Trial name
- NCT01532830
- Testing
- n-VNS
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- ElectroCore INC