Vagus Nerve Stimulation (VNS)

DEVICE10 trials

Sponsors

Cyberonics, Inc., MicroTransponder Inc., University Hospital, Grenoble, LivaNova, University of Pittsburgh

Conditions

ArrhythmiaCongestive Heart FailureCrohn's DiseaseMajor Depressive DisorderSevere TinnitusStrokeTreatment Resistant DepressionTreatment Resistant Depression (TRD)

Phase 1

Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

CompletedNCT01823887

Cyberonics, Inc.Congestive Heart Failure

Start: 2012-07-31End: 2014-06-30Updated: 2015-02-19

Phase 3

Vagus Nerve Stimulation a New Approach in the Treatment of Crohn's Disease

TerminatedNCT01569503

University Hospital, GrenobleCrohn's Disease

Start: 2012-03-31End: 2017-05-30Updated: 2018-05-03

Unknown Phase

Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD)

CompletedNCT00533832

Cyberonics, Inc.Major Depressive Disorder

Start: 2000-07-31End: 2005-07-31Updated: 2007-09-24

Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus

CompletedNCT01253616

MicroTransponder Inc.Severe Tinnitus

Start: 2010-12-31End: 2012-06-30Updated: 2017-02-17

VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

CompletedNCT02243020

MicroTransponder Inc.Stroke, Upper Limb Deficits

Start: 2014-10-31End: 2022-06-01Updated: 2022-09-15

Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

CompletedNCT03163030

Cyberonics, Inc.Congestive Heart Failure

Start: 2014-08-31End: 2021-12-31Updated: 2023-05-06

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

RecruitingNCT03887715

LivaNovaTreatment Resistant Depression

Start: 2019-09-26End: 2030-12-31Target: 6800Updated: 2026-06-15

VNS-induced Corticospinal Plasticity

CompletedNCT04088565

University of PittsburghStroke

Start: 2019-09-22End: 2021-11-09Updated: 2022-11-01

A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation

CompletedNCT04359004

University of California, Los AngelesArrhythmia, Ventricular Tachycardia (VT)

Start: 2020-12-08End: 2023-10-30Updated: 2023-11-13

Treatment Resistant Depression and Vagus Nerve Stimulation

RecruitingNCT05952674

Assistance Publique - Hôpitaux de ParisTreatment Resistant Depression (TRD)

Start: 2024-02-19End: 2033-02-19Target: 166Updated: 2026-06-23

Related Papers

Prognostic and Prescriptive Predictors of Treatment Response to Adjunctive VNS Therapy in Major Depressive Disorder

The Journal of Clinical Psychiatry2025-07-142 citations

Suicide characteristics in patients with marked treatment-resistant major depressive disorder: A RECOVER trial report

Journal of Affective Disorders2024-12-24

Clinical characteristics and treatment exposure of patients with marked treatment-resistant unipolar major depressive disorder: A RECOVER trial report

Brain stimulation2024-03-0112 citations

Autonomic regulation therapy in chronic heart failure with preserved/mildly reduced ejection fraction: ANTHEM-HFpEF study results.

2023-03-1724 citations

Persistent Autonomic Engagement and Cardiac Control After Four or More Years of Autonomic Regulation Therapy Using Vagus Nerve Stimulation

Frontiers in Physiology2022-03-113 citations

Chronic vagus nerve stimulation is associated with multi-year improvement in intrinsic heart rate recovery and left ventricular ejection fraction in ANTHEM-HF.

2021-02-1611 citations

Multi-year improvement in autonomic tone, baroreceptor sensitivity, and cardiac electrical stability using vagus nerve stimulation in patients with HFrEF in the ANTHEM-HF study

European Heart Journal2020-11-01

Vagus nerve stimulation as adjunctive therapy in patients with difficult-to-treat depression (RESTORE-LIFE): study protocol design and rationale of a real-world post-market study.

2020-09-2916 citations

Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke

Stroke2018-10-15178 citations

Novel method to assess intrinsic heart rate recovery in ambulatory ECG recordings tracks cardioprotective effects of chronic autonomic regulation therapy in patients enrolled in the ANTHEM-HF study.

2017-02-175 citations

Autonomic regulation therapy suppresses quantitative T-wave alternans and improves baroreflex sensitivity in patients with heart failure enrolled in the ANTHEM-HF study.

2015-11-1841 citations