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

Deep Brain Stimulation of the STN and Cognitive Control: A Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00917722
Acronym
COVOLT
Enrollment
12
Registered
2009-06-10
Start date
2006-03-31
Completion date
2013-12-31
Last updated
2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease, STN DBS, Deep Brain Stimulation

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.

Interventions

None listed

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026