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Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

NCT03446664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-10-25

No results posted yet for this study

Summary

Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.

Conditions

  • Epilepsies, Partial
  • Epilepsy, Tonic-Clonic

Interventions

DEVICE

Microburst Stimulation

Implantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types.

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Selim Benbadis, MD · University of South Florida Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2021-07-30
Completion
2021-10-27
FDA Device
Yes

Countries

  • United States
  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446664 on ClinicalTrials.gov