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

NCT ID: NCT00917722

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Parkinson's Disease STN DBS Deep Brain Stimulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara G Hershey, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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04-0045

Identifier Type: -

Identifier Source: org_study_id