Clinical trials: Vagus Nerve Diseases
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
Obesity
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity.
- Trial name
- ReCharge (NCT01327976)
- Testing
- vBloc (Active Device)
- Where
- 10 sites in United States, Australia
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- ReShape Lifesciences
Congestive Heart Failure
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure.
- Trial name
- ANTHEM-HF (NCT01823887)
- Testing
- Vagus Nerve Stimulation (VNS)
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Cyberonics, Inc.
Rheumatoid Arthritis
The SetPoint System Safety & Performance Post-Approval Study
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the…
- Trial name
- ACTIVATE (NCT07489326)
- Testing
- SetPoint System
- Volunteers
- 150 people
- Sponsor
- SetPoint Medical Corporation
PTSD, Post Traumatic Stress Disorder PTSD
Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)
The goal of this clinical trial is to evaluate the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for symptoms of post-traumatic stress disorder (PTSD) in…
- Conditions
- PTSD, Post Traumatic Stress Disorder PTSD, PTSD - Post Traumatic Stress Disorder, Post Traumatic Stress Disorder
- Trial name
- NCT07523685
- Testing
- non-invasive vagus nerve stimulation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Acacia Clinics
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
Upper Extremity Paresis, Stroke, Chronic
Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits
This is a single-center, multiphase pilot study of 16 subjects with residual upper extremity deficits at least six months after a supratentorial ischemic or hemorrhagic stroke.
- Trial name
- NCT06288217
- Testing
- NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation), Upper Limb Rehabilitation
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- NeuraStasis, Inc
Obesity
Vagal Blocking for Obesity Control
To determine the safety, efficacy and treatment algorithm(s) of the Maestro System in causing weight loss in obese subjects - This study will provide feasibility data regarding the potential of intra-abdominal vagus nerve…
- Trial name
- NCT00555958
- Testing
- Active, implantable, intra-abdominal vagal blocking medical device
- Where
- 5 sites in Australia, Mexico and 2 more
- Volunteers
- 120 people
- Sponsor
- ReShape Lifesciences
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
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.
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
Epilepsy
Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK.
This is a UK, multi-center, non-interventional study based on the use of health service administrative and medical records (paper-based and/or electronic, as applicable) along with the use of prospectively collected…
- Trial name
- DANTE (NCT04779814)
- Where
- 5 sites in United Kingdom
- Volunteers
- 97 people
- Sponsor
- LivaNova
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
Crohn's Disease
Vagus Nerve Stimulation in Crohn's Disease
This is an open label interventional study using an implantable vagus nerve stimulation device in patients with Crohn's disease who have active disease despite treatment with a tumor necrosis factor (TNF) antagonist drug.
- Trial name
- NCT02311660
- Testing
- Vagus Nerve Stimulation Device
- Where
- 4 sites in Croatia, Italy and 2 more
- Volunteers
- 15 people
- Sponsor
- SetPoint Medical Corporation
Treatment Resistant Depression
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve…
- Trial name
- RESTORE-LIFE (NCT03320304)
- Testing
- Vagal Nerve Simulation (VNS) Therapy
- Where
- 18 sites in Austria, Belgium and 2 more
- Volunteers
- 500 people
- Sponsor
- LivaNova
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.
Asthma
Neurostimulation for the Relief of Acute Bronchoconstriction
The goal of this study is to validate design for the Resolve™ Stimulator and Proximity Electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a…
- Trial name
- NCT00762931
- Testing
- Resolve Stimulator and Proximity Lead
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- ElectroCore INC
Drug Resistant Epilepsy
A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl
This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM.
- Trial name
- AURORA (NCT06340802)
- Testing
- VNS Treatment
- Where
- 2 sites in Belgium
- Volunteers
- 5 people
- Sponsor
- Synergia Medical
Paralysis, Unilateral, Vocal Cord
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
This is a prospective, 2-part, multi-center, open-label, non-randomized clinical trial to assess safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold Paralysis (UVFP).
- Trial name
- NCT05119842
- Testing
- APrevent® VOIS-Implant
- Where
- 7 sites in United States, Austria and 1 more
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- APrevent Biotech GmbH
Dyspepsia, Irritable Bowel Syndrome
A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G
A randomized, sham-controlled, single-centre pilot investigation designed to compare two parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment in subjects with FGIDs.
- Trial name
- NCT02388269
- Testing
- gammaCore®-G
- Where
- United Kingdom
- Volunteers
- 91 people
- Sponsor
- ElectroCore INC