Deep Brain Stimulation (DBS) for the Suppression of Tremor

NCT02087046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2023-04-25

Study results available
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Summary

The purpose of the proposed study is to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System in the VIM nucleus of the thalamus implanted for the treatment of tremor due to essential tremor.

This study will be included in the Pre-Market Approval Application to support the safety of this device in use.

Conditions

Interventions

DEVICE

ANS Totally Implantable Deep Brain Stimulation System

ANS Totally Implantable Deep Brain Stimulation System will be implanted in the VIM nucleus of the thalamus

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Edward Karst · Abbott

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2014-04-30
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT02087046 on ClinicalTrials.gov