Deep Brain Stimulation (DBS) Intrepid Vercise Device for Parkinson's Disease (A5002)

Condition


Study Name

INTREPID STUDY Implantable Neurostimulator for the Treatment of Parkinson’s Disease (IRB no. 30181)


Phase

Phase III


Summary

The purpose of this study is to evaluate whether an investigational device, the Deep Brain Stimulation (DBS) Vercise system, is safe and effective for the treatment of Parkinson’s disease (PD) symptoms when given in addition to optimal medical therapy in patients with advanced PD that is not adequately controlled by medication alone. Researchers will also evaluate changes in patients’ quality of life, dyskinesia (uncontrollable movements) severity, PD medications, and severity of other PD symptoms. The Vercise DBS system consists of a stimulator with a rechargeable battery, two wires, extension cables and burr hole covers that will be implanted in the body and brain.


Eligibility

Key Inclusion Criteria

  • 22-75 years old
  • Diagnosis of bilateral idiopathic PD
  • Duration of PD ≥5 years of motor symptoms

Key Exclusion Criteria

  • Intracranial abnormality or medical condition that would contraindicate DBS surgery
  • Significant psychiatric condition likely to compromise the patient’s ability to comply with study requirements
  • Any other active implanted devices

Please see detailed list of inclusion and exclusion criteria.


Principal Investigator

Michele Tagliati, MD


Contact

Chang (Peter) Kim
Phone: 310-423-8041
Email: chang.kim7@cshs.org