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Recruiting NCT04715984

Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neurophysiology recordings, Neural stimulation.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment

Overview

The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.

Interventions

  • Other Neurophysiology recordings
    Neurophysiology recordings will be performed during deep brain stimulation surgery and their relationship to performance on a gambling task evaluated
  • Other Neural stimulation
    Neural stimulation will be delivered during a gambling task and its impact on task performance quantified

Primary outcome measures

  • Changes in caudate DLPFC beta coherence [Time frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours]
  • Changes in gambling task performance with neural stimulation [Time frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours]
Secondary outcome measures (1)
  • Change in beta power with neural stimulation [Time frame: Baseline to end of deep brain stimulation (DBS) surgery, approximately 3-4 hours]

Eligibility criteria

Inclusion criteria

  • Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center
  • Planned clinical electrode trajectory that contacts caudate
  • Age greater than or equal to 40
  • Diagnosis of Parkinson's disease
  • Able to participate in intraoperative testing
  • English speaking

Exclusion criteria

  • Age less than 40
  • Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)
  • Movement disorder other than Parkinson's disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT04715984 · 201868

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗