Clinical trials: Vagus Nerve Stimulation
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
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
Vagus Nerve Stimulation
Recording Cutaneous Vagal Nerve Activity With Multi-Electrode Array (MEA) in Patients Undergoing VNS Therapy
The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating vagal nerve function. This will be accomplished through several independent, but related, studies.
- Trial name
- NCT06827548
- Testing
- Multi-Electrode Array (MEA) Recording
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Indiana University
Subarachnoid Hemorrhage, Aneurysmal
Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage
This is a single site, randomized, sham-controlled, double blinded pilot study assessing the feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS), gammaCore, in the treatment of headache in subarachnoid…
- Trial name
- VANQUISH (NCT04126408)
- Testing
- gammaCore
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Northwell Health
Chronic Migraine
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect preliminary clinical data related to the safety and clinical benefits of daily use of…
- Trial name
- NCT01667250
- Testing
- GammaCore Active Device
- Where
- 6 sites in United States
- Volunteers
- 59 people
- Sponsor
- ElectroCore INC
Healthy
How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS).
- Trial name
- NCT06614933
- Testing
- Biphasic transcutaneous auricular vagus nerve stimulation, Monophasic transcutaneous auricular vagus nerve stimulation
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Miami
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
Gastroparesis
Vagal Nerve Stimulation for Gastroparesis
This study is investigating a new form of treatment for a digestive disorder called gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction.
- Trial name
- VNS (NCT03120325)
- Testing
- Vagal Nerve Stimulation
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Stanford University
Migraine
Vagus Nerve Stimulation and Stress Reduction Training for Migraine
This study design has two components: 1) a cross-sectional assessment of brain activity and inflammation in migraine patients compared to healthy controls and 2) an assessment of 8 weeks of a combination therapy approach to…
- Trial name
- NCT03592329
- Testing
- Stress Reduction Training A, active tVNS, Stress Reduction Training B
- Where
- United States
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
Learning, taVNS
Learning and Ear Stimulation
This study aims to determine how non-invasive ear stimulation affects learning. During this study, participants will be asked to complete surveys and come to a lab for about 2.5 hours.
- Trial name
- NCT04812015
- Testing
- transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes, taVNS 30 minutes, taVNS 45 minutes
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
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.
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
Epilepsy
Seizure Detection and Automatic Magnet Mode Performance Study
The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model 106 VNS Therapy System.
- Trial name
- E-36 (NCT01325623)
- Testing
- Model 106 VNS Therapy System
- Where
- 14 sites in Belgium, Germany and 3 more
- Volunteers
- 31 people
- Sponsor
- Cyberonics, Inc.
Stroke
taVNS for Upper Limb Rehabilitation
This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear.
- Trial name
- NCT04129242
- Testing
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
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
Parkinson Disease
Combining VNS With PT Interventions for Individuals With PD
The purpose of this study is to evaluate the combined effects of non-invasive neuromodulation (specifically transauricular Vagus Nerve Stimulation) with exercise interventions to improve physical function and quality of life in…
- Trial name
- VNS-PT-PD (NCT05871151)
- Testing
- taVNS, Exercise
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
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
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
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