Clinical trials: Vagus Nerve Stimulation
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
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
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.
Tinnitus
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear.
- Trial name
- NCT01176734
- Testing
- tVNS-Device
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- cerbomed GmbH
Inflammation
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study
The purpose of this study is to assess the effect of transvenous vagus nerve stimulation (tVNS) on the immune response. In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide [LPS]) elicits a…
- Trial name
- NoSIRS (NCT01944228)
- Testing
- Vagal Nerve Stimulation
- Where
- Netherlands
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Autism Spectrum Disorder
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder
Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder
- Trial name
- NCT06473623
- Testing
- vagus nerve stimulation
- Where
- Hong Kong
- Volunteers
- 20 people
- Sponsor
- Neuropix
Rheumatoid Arthritis (RA)
Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis - the TRAVAGA Study
Purpose and aim The overall aim is to investigate efficacy and safety of a newly developed non-invasive auricular investigational device that electrically stimulates the auricular branch of the vagus nerve to activate the…
- Trial name
- TRAVAGA (NCT06779123)
- Testing
- Transauricular vagus nerve stimulation., transauricular vagus nerve non-stimulation
- Where
- 6 sites in Sweden
- Volunteers
- 128 people
- Sponsor
- taVNS AB
Crohn Disease
Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease
This will be an open label multicenter study of the safety and efficacy of an active implantable VNS device in patients with Crohn's Disease.
- Trial name
- NCT02951650
- Testing
- Cyberonics VNS
- Where
- 4 sites in Croatia, Italy and 2 more
- Volunteers
- 15 people
- Sponsor
- SetPoint Medical Corporation
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.
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.
Epilepsy
IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
This is a retrospective non-interventional study to describe the HCRU and clinical outcomes before and after AspireSR® device implantation in subjects with drug resistant epilepsy at the Queen Elizabeth Hospital, Birmingham…
- Trial name
- IMPACT (NCT05975931)
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- LivaNova
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.
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.
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.
Opioid-use Disorder, Opioid Withdrawal
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
- Trial name
- NCT04731935
- Testing
- Sparrow Therapy System
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Spark Biomedical, 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
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.
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.
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