Clinical trials: Vagus Nerve Diseases
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.
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
Ischemic Stroke, Upper Extremity Paresis
A Trial of Rehabilitation Paired With VNS for Motor Function in Patients With Stroke (Repair Study)
The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) paired with rehabilitation for enhancing upper extremity motor function after ischemic stroke.
- Trial name
- NCT06722677
- Testing
- VNS, Rehabilitation
- Where
- 13 sites in China
- Volunteers
- 99 people
- Sponsor
- Beijing Pins Medical Co., Ltd
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.
Vascular Dementia, Mild Cognitive Impairment
Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
This clinical trial evaluates the preliminary effectiveness and safety of Cerogrin, a medical device developed by Neurogrin Inc.
- Trial name
- NCT07149038
- Testing
- Cerogrin
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Neurogrin 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.
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
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
Epilepsy
Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated
Vagus Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy since 1994. This post-market study is designed to follow the clinical course and outcomes for patients with refractory seizures treated…
- Trial name
- V-COMPAS (NCT01281293)
- Where
- 20 sites in United States, Belgium and 3 more
- Volunteers
- 124 people
- Sponsor
- Cyberonics, 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, Morbid
The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol
This is a five-year, single arm, multi-center trial to evaluate the long-term safety and efficacy of the Maestro Rechargeable System in treating obesity. The study will include an observational arm and a randomized sub-study.
- Trial name
- ReNEW (NCT03145636)
- Testing
- vBloc Maestro Rechargeable System, vBloc Achieve Weight Management Program, Control Weight Management (CWM) program
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- ReShape Lifesciences
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
Long COVID Symptoms
Vagal Approaches on Long COVID-19
The purpose of this study is to explore whether two general wellness products, alone or combined, can support individuals experiencing Long COVID symptoms.
- Trial name
- NCT07190105
- Testing
- Sonocea Sonic Augmentation Technology (SAT), Truvaga Electrical Vagus Nerve Stimulator
- Where
- United States
- Volunteers
- 546 people
- Sponsor
- Leidos Life Sciences
Epilepsy
PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1
This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing…
- Trial name
- PuLsE 2 (NCT01281280)
- Where
- 18 sites in Belgium, Canada and 5 more
- Volunteers
- 81 people
- Sponsor
- Cyberonics, Inc.
Tinnitus, Subjective Tinnitus
Efficacy and Safety of the Soricle for Subjective Tinnitus Relief
This study was conducted to evaluate the efficacy and safety of Soricle, a medical device combining transcutaneous vagus nerve stimulation and sound stimulation, in patients with subjective tinnitus.
- Trial name
- NCT07548320
- Testing
- tVNS Device, tVNS + Sound Stimulation Device
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Neurive Co.,Ltd.
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.
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.
Obesity
EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.
- Trial name
- EMPOWER (NCT00521079)
- Testing
- Therapy ON, Therapy OFF
- Where
- 15 sites in United States, Australia
- Volunteers
- 294 people
- Sponsor
- ReShape Lifesciences
Upper Extremity Problem
Vivistim Registry for Paired VNS Therapy (GRASP)
The purpose of the Vivistim Registry for Paired VNS Therapy (GRASP) is to gather real-world information on patients with arm and hand deficits post-stroke who are considering Vivistim System treatment.
- Trial name
- GRASP (NCT05301140)
- Testing
- Vivistim System
- Where
- 16 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- MicroTransponder Inc.