Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63 participants
OBSERVATIONAL
2020-10-15
2024-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Parkinson's Disease patients with DBS, no stimulation
This cohort will serve as as the observed group, displaying basal ganglia pathology.
A syringe pump controlled by Stanpump implementing the Eleveld Pharmacokinetics-Pharmacodynamics (PK-PD) model for propofol will be used as a targeted controlled infusion (TCI) system to achieve plasma target propofol concentrations. Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Experiments will be completed with DBS off.
Propofol
Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Essential Tremor patients with DBS
This cohort will serve as a control group (no basal ganglia pathology). A syringe pump controlled by Stanpump implementing the Eleveld Pharmacokinetics-Pharmacodynamics (PK-PD) model for propofol will be used as a TCI system to achieve plasma target propofol concentrations. Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Experiments will be completed with DBS off.
Propofol
Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Parkinson's Disease patients with DBS, Gpi stimulation
This cohort will serve as as the observed group, displaying basal ganglia pathology.
A syringe pump controlled by Stanpump implementing the Eleveld Pharmacokinetics-Pharmacodynamics (PK-PD) model for propofol will be used as a targeted controlled infusion (TCI) system to achieve plasma target propofol concentrations. Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Participants will be stimulated at the Gpi via DBS leads during propofol induced loss of consciousness.
Propofol
Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Parkinson's Disease patients with DBS, Gpe stimulation
This cohort will serve as as the observed group, displaying basal ganglia pathology.
A syringe pump controlled by Stanpump implementing the Eleveld Pharmacokinetics-Pharmacodynamics (PK-PD) model for propofol will be used as a targeted controlled infusion (TCI) system to achieve plasma target propofol concentrations. Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Participants will be stimulated at the Gpe via DBS leads during propofol induced loss of consciousness.
Propofol
Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Parkinson's Disease patients undergoing DBS surgery, Gpe stimulation
A syringe pump controlled by Stanpump implementing the Eleveld Pharmacokinetics-Pharmacodynamics (PK-PD) model for propofol will be used as a targeted controlled infusion (TCI) system to achieve plasma target propofol concentrations. Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Participants will be stimulated at the Gpe via DBS leads, and cortical activity will be recorded via ECoG during propofol induced loss of consciousness.
Propofol
Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Parkinson's Disease patients undergoing DBS surgery, Gpi stimulation
A syringe pump controlled by Stanpump implementing the Eleveld Pharmacokinetics-Pharmacodynamics (PK-PD) model for propofol will be used as a targeted controlled infusion (TCI) system to achieve plasma target propofol concentrations. Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Participants will be stimulated at the Gpi via DBS leads, and cortical activity will be recorded via ECoG during propofol induced loss of consciousness.
Propofol
Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Parkinson's Disease patients undergoing DBS surgery, no stimulation
A syringe pump controlled by Stanpump implementing the Eleveld Pharmacokinetics-Pharmacodynamics (PK-PD) model for propofol will be used as a targeted controlled infusion (TCI) system to achieve plasma target propofol concentrations. Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Participants will not receive any stimulation via DBS leads, and cortical activity will be recorded via ECoG during propofol induced loss of consciousness.
Propofol
Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Interventions
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Propofol
Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Parkinson's disease or essential tremor
* Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
Exclusion Criteria
* Neurocognitive testing indicating amnestic cognitive deficits
* History of intolerance of propofol or medical indications to use an anesthetic other than propofol
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Nader Pouratian
Professor of Medicine
Principal Investigators
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Nader Pouratian, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Nader Pouratian
Dallas, Texas, United States
Countries
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Other Identifiers
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STU-2021-0396
Identifier Type: -
Identifier Source: org_study_id
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