Deep brain stimulation (DBS) is an effective treatment for many patients with advanced stage Parkinson’s disease (PD) when symptoms are not adequately controlled with medication. Vanderbilt University recently completed a U.S. Food and Drug Administration (FDA)-approved pilot clinical trial of safety and tolerability of DBS in early-stage PD. Based on the results of the pilot, the FDA approved Vanderbilt University to conduct a large-scale, multicenter clinical trial evaluating the safety and efficacy of DBS in very early stage Parkinson’s disease.
This trial will evaluate whether DBS applied in very early stage Parkinson’s disease is superior to traditional medical therapy, improves quality of life, and delays the development of complications associated with medications.
All participants will be implanted with a DBS device and will receive traditional PD medication throughout the entire course of the study. DBS therapy during the first two years, however, will be randomized, with half of the participants receiving stimulation in addition to medications and the other half receiving only medications. Then all participants will receive stimulation plus medication for an additional two years.
Impact on Diagnosis/Treatment of Parkinson’s Disease:
This research effort will help the field understand if DBS applied during early stage PD is safe and may improve quality of life, offering an alternative therapy to those who do not respond well to oral medications.
Next Steps for Development:
MJFF funding provides essential support to launch this large-scale multicenter study.