Clinical trials: Vagal Nerve Stimulation
- Condition Vagal Nerve Stimulation
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Cerebrovascular Stroke, Upper Extremity Paresis
Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment.
- Trial name
- VNS-REHAB (NCT03131960)
- Testing
- Paired Vagus Nerve Stimulation, Rehabilitation
- Where
- 20 sites in United States, United Kingdom
- Volunteers
- 108 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
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.
Chronic Obstructive Pulmonary Disease
Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment
The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day over a course of 2 months.
- Trial name
- NCT01679314
- Testing
- AlphaCore device
- Where
- Germany
- Volunteers
- 54 people
- Sponsor
- ElectroCore 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
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
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
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
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
Epilepsy
Seizure Detection and Automatic Magnet Mode Performance Study
The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model 106 VNS Therapy System.
- Trial name
- E-36 (NCT01325623)
- Testing
- Model 106 VNS Therapy System
- Where
- 14 sites in Belgium, Germany and 3 more
- Volunteers
- 31 people
- Sponsor
- Cyberonics, 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
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
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
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.
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.
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
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.
Rheumatoid Arthritis
Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or…
- Trial name
- RESET-RA (NCT04539964)
- Testing
- Implant Procedure, Conventional Synthetic DMARD, Active stimulation
- Where
- 42 sites in United States
- Volunteers
- 243 people
- Sponsor
- SetPoint Medical Corporation