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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00917722
First received: June 8, 2009
Last updated: June 9, 2009
Last verified: June 2009
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deep Brain Stimulation of the STN and Cognitive Control: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Enrollment: 12
Study Start Date: March 2006
Estimated Study Completion Date: December 2013
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917722

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Tamara G Hershey, PhD Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Tamara G Hershey PhD., Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00917722     History of Changes
Other Study ID Numbers: 04-0045
Study First Received: June 8, 2009
Last Updated: June 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Parkinson's Disease
STN DBS
Deep Brain Stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014