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

Parkinson's Disease Clinical Trial

— COVOLT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917722
• Other study ID #: 04-0045
• Status: Completed
• Phase: N/A
• First received: June 8, 2009
• Last updated: November 9, 2016
• Start date: March 2006
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

External Links

•   Link to Dr. Hershey's Web Site