A clinical study involves treating and following a group of participants to see if a particular therapy is a safe and effective way of treating a specific condition. The FDA (Food and Drug Administration) approves and regulates clinical studies in the United States. ANS, the clinical study’s sponsor, has received FDA approval for this clinical study to evaluate the Libra® DBS system for the treatment of essential tremor.

ANS is performing this study of its device, the Libra DBS system, for people with essential tremor of the arm and/or hand that is not adequately controlled by drugs.

The study will be open to approximately 160 participants at approximately 12 sites in the United States. All participants will be implanted with a neurostimulator and followed for 12 months, with long-term follow-up until the device is approved or the study is stopped. In addition to having tremor of the arm or hand that is not adequately controlled by drugs, participants must have been diagnosed with essential tremor at least 3 years ago and must be at least 18 years old. Participants can continue to receive their tremor medications, as needed, while participating in the study.