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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917722
First Posted: June 10, 2009
Last Update Posted: November 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 8, 2009
First Posted: June 10, 2009
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This was a small pilot study and consent was not obtained to share data.

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