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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00917722
First received: June 8, 2009
Last updated: January 7, 2016
Last verified: January 2016
  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
Study Completion Date: December 2013
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: 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: January 7, 2016
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 August 22, 2016