Clinical trials: Vagus Nerve Stimulations
Blood Loss, Surgical
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
- Trial name
- NCT06647017
- Testing
- Volta tAN System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University Surgical Vascular
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
Alcohol Use Disorder, Alcohol Abuse
tAN for Substance Use Disorder
The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD).
- Conditions
- Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State
- Trial name
- NCT07281261
- Testing
- Sparrow Ascent
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Spark Biomedical, Inc.
Epilepsy, Seizures
Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
- Conditions
- Epilepsy, Seizures, Drug Resistant Epilepsy
- Trial name
- CORE-VNS (NCT03529045)
- Testing
- Vagus Nerve Stimulation (VNS) Therapy
- Where
- 62 sites in United States, Australia and 14 more
- Volunteers
- 827 people
- Sponsor
- LivaNova
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
Drug-Refractory Epilepsy
Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy
To evaluate the performance of automatic stimulation mode of a new rechargeable implantable vagus nerve stimulation system for drug-refractory epilepsy
- Trial name
- NCT05993117
- Testing
- G114R VNS system
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Beijing Pins Medical 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
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
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
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.
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
Migraine
A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine (REAL)
This is a randomized study for the prevention and acute treatment of migraine using open label nVNS and standard of care versus standard of care. .
- Trial name
- REAL (NCT03787238)
- Testing
- non-invasive vagus nerve stimulation
- Where
- 17 sites in Denmark, Germany and 3 more
- Sponsor
- ElectroCore INC
Opioid-use Disorder, Opioid Withdrawal
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
- Trial name
- RESTORE (NCT05053503)
- Testing
- Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- Spark Biomedical, Inc.
Acute Stress Reaction, Cognitive Performance
Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.
- Trial name
- ASR (NCT06390267)
- Testing
- Sparrow Hawk (Active)
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Spark Biomedical, Inc.
Stroke
Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group…
- Trial name
- NCT01669161
- Testing
- Vivistim System, Rehab Only
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- MicroTransponder Inc.
Epilepsy
VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)
Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator
- Trial name
- E-37 (NCT01846741)
- Testing
- M106 VNS Therapy System
- Where
- 15 sites in United States
- Volunteers
- 20 people
- Sponsor
- Cyberonics, Inc.
Chronic Obstructive Pulmonary Disease
Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations
This study will look at the safety, improving symptoms and decreasing the length of stay of patients admitted to the hospital with COPD.
- Trial name
- NCT01612793
- Testing
- AlphaCore Device
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- ElectroCore INC
Migraine Disorders
Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.
- Trial name
- NCT03716505
- Testing
- gammaCore Sapphire active
- Where
- 30 sites in United States
- Volunteers
- 231 people
- Sponsor
- ElectroCore INC
Severe Tinnitus
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus.
- Trial name
- NCT01253616
- Testing
- vagus nerve stimulation (VNS)
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- MicroTransponder Inc.
Diabetes Mellitus, Type 2
Acute Study of Effect of Ultrasound Vagus Nerve Stimulation on Glycemia
This is an early feasibility study to evaluate the proof of concept of modulation of glycemia by non-invasive ultrasound vagus nerve stimulation.
- Trial name
- NCT04094649
- Testing
- Ultrasound Vagus Nerve Stimulation (DECIMA)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Aucta Technologies, Inc.