Clinical trials: Vagus Nerve Stimulations
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.
Refractory Epilepsy
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms.
- Trial name
- NCT03062514
- Testing
- PINS Vagus Nerve Stimualtor
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Beijing Pins Medical Co., Ltd
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
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
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
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
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.
Migraine
RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks
This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment)…
- Trial name
- NCT02686034
- Testing
- gammaCore-S
- Where
- 10 sites in Italy
- Volunteers
- 285 people
- Sponsor
- ElectroCore INC
Heart Failure With Reduced Ejection Fraction
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.
- Trial name
- VANGUARD (NCT02113033)
- Testing
- Equilia® Vagal Nerve Stimulation
- Where
- 6 sites in Belgium, France and 2 more
- Volunteers
- 15 people
- Sponsor
- LivaNova
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
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.
Epilepsy
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
- Trial name
- NCT01178437
- Testing
- T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- cerbomed GmbH
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
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.
Hemostasis, Blood Biomarkers
Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus…
- Trial name
- HHS (NCT05977946)
- Testing
- Volta System
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Spark Biomedical, Inc.
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
Chronic Cluster Headache
Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
Subjects enrolled into this 10 week study will for the first two weeks document the number of cluster headaches and the means of treating (medication) of these attacks. Subjects will then be randomized to into either two groups.
- Trial name
- NCT01701245
- Testing
- GammaCore
- Where
- 10 sites in Belgium, Germany and 2 more
- Volunteers
- 97 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
Epileptic Encephalopathy
Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.
- Trial name
- NCT02603991
- Testing
- PINS Vagus Nerve Stimulator, Levetiracetam
- Where
- China
- Volunteers
- 1 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Alcohol Use Disorder
A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear
Alcohol Use Disorders (AUD's) are a major health and social problem. Relapse is a rule rather than an exception in alcohol dependence, leading to poor outcomes. Craving are frequently associated with relapse.
- Trial name
- NCT04106739
- Testing
- Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS)
- Where
- India
- Volunteers
- 44 people
- Sponsor
- DyAnsys, Inc.