Clinical Study Description

The Libra® DBS system is being used under an FDA-approved Investigational Device Exemption (IDE) to investigate unilateral and bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of tremor in the upper extremities of patients with essential tremor that is not adequately controlled with medication. The device used in this study is categorized as investigational (non-experimental) and, as such, is eligible for Medicare reimbursement.

Approximately 160 patients will be followed in this prospective, randomized, double-blind study at approximately 12 medical centers in the United States. Detailed inclusion and exclusion criteria for individual patients, and additional study details can be discussed with the participating clinical sites.

All participants will be implanted unilaterally and after six months have the option to be implanted bilaterally. All participants will be monitored for 12 months following their initial implant, with long-term follow-up until the device is approved or the study is stopped. Participants will continue to receive their tremor medication during the study.

Where can medical professionals learn more about treatment options for essential tremor?

The American Academy of Neurology has published an evidence-based guideline reviewing all of the evidence for pharmacologic and surgical therapies for essential tremor. The AAN Therapies for Essential Tremor guidelines provides information on the duration of effect, relative benefits and risks, and the strength of evidence supporting the use of the pharmacologic and surgical therapies for essential tremor.

Where can medical professionals learn more about DBS for essential tremor?

DBS for essential tremor has been performed for almost 20 years, and numerous clinicians have published their results. Conduct a PubMed™ or other search to find journal articles in this field.