IRB Number:

2226-05

Trial status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System when implanted for the treatment of tremor due to essential tremor (ET).

Who is eligible to participate?

• Both males and females from 18 years and above are eligible for the study.


• 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 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.

What is involved?

Participants in this research study will undergo the following:

• Each patient will be screened and then undergo a baseline evaluation followed by unilateral implantation of the DBS system. DBS is the electric stimulation of a specific area of the brain using a DBS system lead and a small pacemaker device called a neurostimulator. During the implantation procedure, each patient will undergo a trial of stimulation in the operating room. The device may be internalized after a successful operative trial or at a later surgery (no later than 4 weeks after initial lead placement). If the device is not activated immediately post-surgery, the patient may return to the clinic to determine optimum stimulation programming. Device programming will be optimized in as many visits as necessary following implantation. The day that the device is fully implanted will be classified as "day 0" for each patient.


• After Day 0 the patient will return to clinic for evaluations at Day 90, Day 180, and Day 365.

How long is the study?

Your participation in the study may take up to 12 months. There is a minimum of 5 visits to the clinic that will be needed.

Who can I contact for additional information?

To participate in this research study or to obtain more information, please call (904) 953-6096 in Jacksonville, Florida, or (507)-266-3044 in Rochester, Minnesota.

Where is the trial located?

• Rochester, MN
• Jacksonville, FL

Last updated: 03/08/2010