Deep Brain Stimulation of the Subthalamic Nucleus (STN) and Cognitive Control

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Meet criteria for "definite" Parkinson's Disease (PD)
STN stimulators on both sides (right and left)
Surgery done at Washington University within 2 years

Exclusion criteria

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Deep Brain Stimulation of the STN and Cognitive Control: A Pilot Study

Acronym: COVOLT

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2013
First posted: Jun 10, 2009
Registry last updated: Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed