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Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-epileptic Drug Treatment in Children With Refractory Seizures

2014-07-23 21:09:18 | BioPortfolio

Summary

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). Seizure reduction, quality of life measures, and side effect profiles will be evaluated. The results of this study will provide controlled comparative data to better guide physicians in determining the best overall treatment strategy for patients with seizures who have failed initial AED therapy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Epilepsy

Intervention

Anti-epileptic drug (AED) therapy, Vagus Nerve Stimulation (VNS) Therapy

Location

Medical University of Vienna - Vienna General Hospital (AKH)
Vienna
Austria

Status

Terminated

Source

Cyberonics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:18-0400

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Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradi...

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Vagal 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 ...

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Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.

PubMed Articles [25468 Associated PubMed Articles listed on BioPortfolio]

Estimating Long-Term Vagus Nerve Stimulation Effectiveness: Accounting for Antiepileptic Drug Treatment Changes.

To investigate the effectiveness of vagus nerve stimulation (VNS) in combination with pharmacological therapy in a longitudinal retrospective study at a single center.

Experience and Solution of Complications of Vagus Nerve Stimulation Therapy in 139 Implant Patients with Medically Refractory Epilepsy.

Vagus nerve stimulation(VNS)for patients with intractable epilepsy was approved by the Japan Ministry of Health, Labour and Welfare in 2010. More than 1,500 VNS systems were implanted by the end of Au...

Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study.

To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, d...

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In the context of the first clinical trial of vagus nerve stimulation (VNS) in Crohn's disease (CD), our main objective was to quantify the acute and chronic effects of VNS on brain activity in CD pat...

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review.

Electrical stimulation of the auricular branch of the vagus nerve (ABVN) via transcutaneous auricular vagus nerve stimulation (taVNS) may influence afferent vagal networks. There have been 5 prior taV...

Medical and Biotech [MESH] Definitions

An adjunctive treatment for PARTIAL EPILEPSY and refractory DEPRESSION that delivers electrical impulses to the brain via the VAGUS NERVE. A battery implanted under the skin supplies the energy.

Traumatic injuries to the VAGUS NERVE. Because the vagus nerve innervates multiple organs, injuries in the nerve fibers may result in any gastrointestinal organ dysfunction downstream of the injury site.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Therapy with two or more separate preparations given for a combined effect.

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

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Relevant Topics

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Epilepsy
Epilepsy is defined as a disorder of brain function characterized by recurrent seizures that have a sudden onset.  (Oxford Medical Dictionary).  A seizure is caused by a sudden burst of excess electrical activity in the brain, causing a tempora...


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