Clinical trials: Nervous Vagus
Refractory Epilepsy
Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.
- Trial name
- VNSRE (NCT02378792)
- Testing
- Vagus Nerve Stimulation
- Where
- 5 sites in China
- Volunteers
- 300 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Epilepsies, Partial
Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures refractory to at least two, but not more than five…
- Trial name
- NCT00215215
- Testing
- Vagus Nerve Stimulation Therapy
- Where
- 23 sites in United States
- Volunteers
- 360 people
- Sponsor
- Cyberonics, Inc.
Duchenne Muscular Dystrophy (DMD)
Can External Vagus Nerve Stimulation Reduce Systemic Levels of Inflammatory Mediators in Duchenne Muscular Dystrophy Patients?
The intended investigation is a pilot study to evaluate the safety and efficacy of a novel transcutaneous auricular vagus nerve stimulator system, termed TRAVAGUS ONE, to reduce systemic levels of inflammatory mediators in…
- Trial name
- Travagus One (NCT07543302)
- Testing
- Transcutaneous auricular vagus nerve stimulation
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- taVNS AB
Lennox-Gastaut Syndrome
Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.
- Trial name
- NCT02632149
- Testing
- PINS Vagus Nerve Stimulator
- Where
- 5 sites in China
- Volunteers
- 31 people
- Sponsor
- Beijing Pins Medical Co., Ltd
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
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
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.
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
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.
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.
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.
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
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
Epilepsies, Partial, Epilepsy, Tonic-Clonic
Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
- Trial name
- Microburst (NCT03446664)
- Testing
- Microburst Stimulation
- Where
- 9 sites in United States, Belgium
- Volunteers
- 33 people
- Sponsor
- LivaNova