Clinical trials: Vagus Nerve Diseases
Pain, Migraine
Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness
The researchers propose studying Gulf veterans with Gulf War Illness (GWI), characterized by a problem with widespread pain. Besides their pain, the researchers will also assess the effect of vagus nerve stimulation (VNS) in…
- Trial name
- NCT02791893
- Testing
- VNS device, Inactive device
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Benjamin Natelson
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.
Obesity
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity.
- Trial name
- ReCharge (NCT01327976)
- Testing
- vBloc (Active Device)
- Where
- 10 sites in United States, Australia
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- ReShape Lifesciences
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.
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
Crohn Disease
Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study
To assess the safety and efficacy of transcutaneous vagal stimulation in adult patients with active Crohn's disease.
- Trial name
- VNS (NCT05165108)
- Testing
- Vagal Nerve Stimulator
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Atrial Fibrillation, Inflammation
Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation
Atrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at voltages substantially below that which slowed the…
- Trial name
- TREAT-AF (NCT02548754)
- Testing
- Parasym device
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of Oklahoma
Delirium
TaVNS for Delirium
The goal of this clinical trial is to test whether a non-invasive device called transauricular vagus nerve stimulation (taVNS) is safe, practical, and potentially helpful for patients in the hospital who develop delirium.
- Trial name
- NCT07258082
- Testing
- Transauricular Vagus Nerve Stimulation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stony Brook University
Raynaud Phenomenon, Primary Raynaud Phenomenon
Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena.
Raynaud's phenomenon (RP) is a common vascular disorder that affects approximately 10% of the general population. RP is associated with significant morbidity that may include loss of the digits due to repeated episodes of…
- Conditions
- Raynaud Phenomenon, Primary Raynaud Phenomenon, Raynaud Disease, Raynaud Syndrome
- Trial name
- NCT03869008
- Testing
- gammaCore Sapphire
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of Toledo Health Science Campus
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
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.
Infant of Diabetic Mother, Oxidative Stress
NAC +taVNS in IDM Who Are Poor Oral Feeders
Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired…
- Conditions
- Infant of Diabetic Mother, Oxidative Stress, Vagus Nerve Stimulation, Feeding Disorders
- Trial name
- NCT04632069
- Testing
- N acetyl cysteine + vagus nerve stimulation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medical University of South Carolina
Obesity
EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.
- Trial name
- EMPOWER (NCT00521079)
- Testing
- Therapy ON, Therapy OFF
- Where
- 15 sites in United States, Australia
- Volunteers
- 294 people
- Sponsor
- ReShape Lifesciences
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
Muscle Tension Dysphonia, Vocal Fold Palsy
Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment
A feasibility study to identify the immediate effect on the voices of patients with voice disorders (muscle tension dysphonia, vocal fold palsy or presbylaryngis) produced by exercising with Acapella Choice as a form of…
- Conditions
- Muscle Tension Dysphonia, Vocal Fold Palsy, Vocal Cord Paralysis, Presbylarynx
- Trial name
- NCT04764604
- Testing
- Acapella Choice, Tube-in-water
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- University College, London
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
Parkinson Disease
taVNS in Mild to Moderate Parkinson's Disease
The purpose of this study is to find out whether a non-invasive form of nerve stimulation called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with Parkinson's Disease.
- Trial name
- taVNS (NCT04157621)
- Testing
- Active taVNS
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Medical University of South Carolina
Neuropathic Pain
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
The purpose of this study is to: 1. Development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation…
- Trial name
- NCT05896202
- Testing
- taVNS Video, Educational materials, TMS Video
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Miami
Long COVID, Chronic Fatigue Syndrome
Vagus Nerve Stimulation as Treatment for Long Covid
Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using…
- Trial name
- NCT05608629
- Testing
- Transcutaneous Non-Invasive Vagus Nerve Stimulation
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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.