Clinical trials: Vagus Nerve Diseases
Asthma
Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to Asthma
The objective of this feasibility research study is to gather preliminary clinical data regarding the safety and potential clinical benefit of noninvasive neurostimulation of the vagus nerve with the AlphaCore™ system for the…
- Trial name
- BC-SA-01 (NCT01385306)
- Testing
- AlphaCore System
- Where
- 5 sites in South Africa
- Volunteers
- 6 people
- Sponsor
- ElectroCore INC
Von Willebrand Disease, Type 1, Heavy Menstrual Bleeding
Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease
The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease…
- Trial name
- VWD/HMB (NCT06064851)
- Testing
- Volta System
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Five Liters, 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
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.
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
Vocal Fold Palsy, Vocal Cord Paralysis
A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid
The primary study goal is to evaluate the histological characteristic of Silk Voice to evaluate the potential for Silk Voice to deliver long-term results to patients.
- Conditions
- Vocal Fold Palsy, Vocal Cord Paralysis, Vocal Cord Atrophy
- Trial name
- NCT04315415
- Testing
- Silk Voice
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sofregen Medical, Inc.
Paralysis, Unilateral, Vocal Cord
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after…
- Trial name
- NCT03864757
- Testing
- thyroplasty implant
- Where
- Austria
- Volunteers
- 8 people
- Sponsor
- APrevent Biotech GmbH
Rheumatoid Arthritis
Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete…
- Trial name
- NCT03437473
- Testing
- SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
- Where
- 4 sites in United States
- Volunteers
- 14 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.
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
Rheumatoid Arthritis
Long Term Extension Study For SPM-005 Participants
This will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis.
- Trial name
- NCT01552538
- Testing
- Cyberonics VNS System
- Where
- 4 sites in Bosnia and Herzegovina, Croatia and 1 more
- Volunteers
- 18 people
- Sponsor
- SetPoint Medical Corporation
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.
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
Stress Disorder, Stress
Sensate II Utilization and Perceived Stress in Adults
Sensate® is A commercially marketed (FCC #: 2AS9ESEN231) stress management wellness device (BioSelf Technology; London, UK). This non-invasive wellness device is one component of a cross-modal (acoustic and aural) sensory…
- Trial name
- NCT05519995
- Where
- United Kingdom
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- BioSelf Technology
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
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
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.
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.
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
Schizophrenia
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.
- Trial name
- 02VNS2009 (NCT01176721)
- Testing
- t-VNS verum
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- cerbomed GmbH