Deep Brain Stimulation of the Subthalamic Nucleus (STN) and Cognitive Control (COVOLT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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In this study, the investigators will follow patients who have had stimulators implanted, at their usual clinic follow-up appointments 3, 6, 9 and 12 months after surgery. It is typical at these appointments for patients to be off medication and for the stimulators to be turned off to observe disease progress and test stimulator effectiveness. Also as part of standard clinical practice, stimulator settings are adjusted for optimal benefit to motor symptoms. Only patients who already have implants will be invited to participate in this study, and no changes to stimulator settings are made for the purposes of this study. Stimulator settings are changed based on clinical evaluation of motor symptoms, and this study has no bearing on how stimulators will be set nor how often they will be set.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Only patients who already have implants will be invited to participate in this study, and no changes to stimulator settings are made for the purposes of this study.
Meet criteria for "definite" Parkinson's Disease (PD)
STN stimulators on both sides (right and left)
Surgery done at Washington University within 2 years
Significant visual deficits (e.g. double vision, untreated eyelid apraxia, blepharospasm) Must be able to see screen
Secondary Parkinsonism (drug-induced or other known etiologies)
Brain injury or defect: history of serious head injury, stroke, encephalitis, defect found on brain imaging
Early severe dementia (within first year of onset) or on cholinesterase inhibitors
Pre-surgical Mini Mental Status exam score < 24
Significant current psychiatric diagnoses (such as depression or psychosis) or on neuroleptics