Deep Brain Stimulation (DBS) for the Suppression of Tremor (NCT02087046) | Clinical Trial Compass
CompletedNot Applicable
Deep Brain Stimulation (DBS) for the Suppression of Tremor
United States127 participantsStarted 2005-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient or authorized representative has signed an informed consent.
✓. Patient is over 18 years of age.
✓. Patient is diagnosed with essential tremor for at least 3 years.
✓. Patient has a disabling medical-refractory upper extremity tremor with no evidence of supraspinal central nervous system disease or injury (tremor not adequately controlled by medications for at least three (3) months before implant).
✓. Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor.
✓. Patient will maintain a constant dose of anti-tremor medication indicated as best medical management for one (1) month prior to enrollment in study.
✓. Patient is available for appropriate follow-up times for the length of the study.
Exclusion criteria
✕. Patient is not surgical candidate;
✕. Patient has other clinically or medically significant disease;
✕. Patient has any neurological injury or disease other than essential tremor;
✕. Patient has any condition requiring repeated MRI scans;
✕. Patient has any condition requiring diathermy;
What they're measuring
1
Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer
Timeframe: Day 180
2
Primary Safety Endpoint: Percentage of Participants With Device-related or Procedure Related Adverse Events
Timeframe: Within 180 days following the initial implant