Clinical trials: Vagal Nerve Stimulation
Epilepsy, Sudden Cardiac Death
Optimization of VNS in Epileptic Patients to Induce Cardioprotection
This study is a non-randomized, prospective study in patients with a diagnosis of epilepsy and previously implanted FDA approved Vagus Nerve Stimulation (VNS) devices.
- Trial name
- NCT04387435
- Testing
- A change or titration in the current or frequency settings of the VNS therapy system.
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of California, Los Angeles
Major Depressive Disorder
Vagus Nerve Stimulation: Integration of Behavior and Cardiac Modulation
This study characterized the impact of respiratory-gated transcutaneous vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry, vagal tone and depressed mood in patients with major depressive disorder…
- Trial name
- tVNS-MDD (NCT04467164)
- Testing
- exhalatory-gated transcutaneous vagus nerve stimulation (e-RAVANS), Inhalatory-gated transcutaneous vagus nerve stimulation (i-RAVANS)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Massachusetts General Hospital
Stroke, Cerebrovascular Accident (CVA)
Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke
The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke…
- Conditions
- Stroke, Cerebrovascular Accident (CVA), Hemiparesis
- Trial name
- tVNS (NCT03592745)
- Testing
- Transcutaneous Vagus Nerve Stimulation (tVNS)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Northwell Health
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
Functional Gastrointestinal Disorders
Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation
This study is to determine if the auricular microstimulator produces the expected increase in HRV.
- Trial name
- NCT05987813
- Testing
- TENS Unit
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Virginia Commonwealth University
Tinnitus
Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized, controlled, parallel study design.
- Trial name
- NCT01962558
- Testing
- VNS Treatment, VNS Control
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- MicroTransponder Inc.
Acute Ischemic Stroke
Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct
This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions…
- Trial name
- NUVISTA (NCT05390580)
- Testing
- transcutaneous auricular vagal nerve stimulation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Washington University School of Medicine
Healthy Young Adults
Noninvasive Vagus Nerve Stimulation (VNS) for Neuromotor Adaptations
The study will examine how electrical stimulation of vagus nerve (i.e. nerve around the outer ear) from the skin surface during motor training influences a brain hormone (called norepinephrine), brain activity, and motor…
- Trial name
- NCT03628976
- Testing
- tVNS, Motor training
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Georgia Institute of Technology
Cluster Headache
A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache.
The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches. Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks.
- Trial name
- NCT01958125
- Testing
- gammaCore
- Where
- 9 sites in Denmark, Germany and 2 more
- Volunteers
- 102 people
- Sponsor
- ElectroCore INC
Cerebrovascular Stroke, Upper Extremity Paresis
Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment.
- Trial name
- VNS-REHAB (NCT03131960)
- Testing
- Paired Vagus Nerve Stimulation, Rehabilitation
- Where
- 20 sites in United States, United Kingdom
- Volunteers
- 108 people
- Sponsor
- MicroTransponder Inc.
Parkinson Disease
taVNS in Mild to Moderate Parkinson's Disease
The purpose of this study is to find out whether a non-invasive form of nerve stimulation called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with Parkinson's Disease.
- Trial name
- taVNS (NCT04157621)
- Testing
- Active taVNS
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Medical University of South Carolina
Low Back Pain
Auricular Vagus Nerve Stimulation for Chronic Pain
This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain.
- Trial name
- NCT03959111
- Testing
- Stimulation at Location 1, Stimulation at Location 2
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Massachusetts General Hospital
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
Infant Development, Hemiplegia
CIMT and taVNS for Hemiplegia in Infants
Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body.
- Conditions
- Infant Development, Hemiplegia, Constraint Induced Movement Therapy
- Trial name
- NCT05101707
- Testing
- transcutaneous auricular vagus nerve stimulation, Constraint induced movement therapy
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Medical University of South Carolina
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
Migraine
RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks
This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment)…
- Trial name
- NCT02686034
- Testing
- gammaCore-S
- Where
- 10 sites in Italy
- Volunteers
- 285 people
- Sponsor
- ElectroCore INC
Ischemic Stroke, Thrombotic Stroke
Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke.
Autonomic modulation by transcutaneous vagal nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: a phase IIa, sham controlled randomised trial.
- Conditions
- Ischemic Stroke, Thrombotic Stroke, Autonomic Dysfunction, Autonomic Imbalance
- Trial name
- VANS (NCT05417009)
- Testing
- trans-cutaneous auricular sensory stimulation
- Where
- United Kingdom
- Volunteers
- 36 people
- Sponsor
- Queen Mary University of London
Stroke, Stroke, Ischemic
At-Home taVNS - Stroke Rehab
Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear.
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- Trial name
- NCT06616831
- Testing
- Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Medical University of South Carolina
Post COVID Syndrome, Fatigue
Vagal Nerve Stimulation for Post COVID Fatigue
The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.
- Conditions
- Post COVID Syndrome, Fatigue, Headache
- Trial name
- NCT05445427
- Testing
- vagal nerve stimulator
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Mayo Clinic
Rheumatoid Arthritis
Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or…
- Trial name
- RESET-RA (NCT04539964)
- Testing
- Implant Procedure, Conventional Synthetic DMARD, Active stimulation
- Where
- 42 sites in United States
- Volunteers
- 243 people
- Sponsor
- SetPoint Medical Corporation