At a glance
ClinicalIndex Comparison RecordN/ACompleted· 127 enrolled
Drug / intervention
ANS Totally Implantable Deep Brain Stimulation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Evaluation of the Advanced Neuromodulation System (ANS) Totally Implantable Deep Brain Stimulation System for the Suppression of Tremor in the Upper Extremities of Patients With Essential Tremor.
In Brief
A clinical study evaluating ANS Totally Implantable Deep Brain Stimulation System for Tremor and 3 related conditions. Completed, enrolled 127 participants across 12 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTremor, Action Tremor, Essential Tremor, Tremor, Limb
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
First PostedMar 2014
Primary CompletionApr 2014
Study CompletionDec 2017
TodayJul 2026
First PostedMar 14, 2014
Enrollment StartOct 1, 2005
Primary CompletionApr 1, 2014
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 12.3 years ago
Interventions
ANS Totally Implantable Deep Brain Stimulation Systemdevice
ANS Totally Implantable Deep Brain Stimulation System will be implanted in the VIM nucleus of the thalamus