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

NCT00917722 | Completed

• 1 other identifier: 04-0045
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; STN DBS; Deep Brain Stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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 & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Tamara G Hershey, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: March 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2013
• Last Updated: November 10, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)