Trial Outcomes & Findings for Brain Networks and Consciousness (NCT NCT04502550)

NCT ID: NCT04502550

Last Updated: 2026-06-08

Results Overview

Average targeted serum dose of propofol at which 50% of patients had loss of behavioral responses

Recruitment status

TERMINATED

Target enrollment

57 participants

Primary outcome timeframe

Baseline visit

Results posted on

2026-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	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 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.
Overall Study STARTED	23	22	12
Overall Study COMPLETED	23	22	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Networks and Consciousness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parkinson's Disease Patients With DBS, no Stimulation n=23 Participants 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 n=22 Participants 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 n=12 Participants 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.	Total n=57 Participants Total of all reporting groups
Age, Continuous	63 years n=9 Participants	71 years n=27 Participants	—	—	—	—	67 years n=23 Participants	66 years n=22 Participants
Sex: Female, Male Female	6 Participants n=9 Participants	3 Participants n=27 Participants	—	—	—	—	6 Participants n=23 Participants	15 Participants n=22 Participants
Sex: Female, Male Male	17 Participants n=9 Participants	19 Participants n=27 Participants	—	—	—	—	6 Participants n=23 Participants	42 Participants n=22 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	—	—	—	—	0 Participants n=23 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Asian	2 Participants n=9 Participants	0 Participants n=27 Participants	—	—	—	—	0 Participants n=23 Participants	2 Participants n=22 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	—	—	—	—	0 Participants n=23 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Black or African American	1 Participants n=9 Participants	1 Participants n=27 Participants	—	—	—	—	1 Participants n=23 Participants	3 Participants n=22 Participants
Race (NIH/OMB) White	19 Participants n=9 Participants	20 Participants n=27 Participants	—	—	—	—	10 Participants n=23 Participants	49 Participants n=22 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	1 Participants n=27 Participants	—	—	—	—	1 Participants n=23 Participants	2 Participants n=22 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	0 Participants n=27 Participants	—	—	—	—	0 Participants n=23 Participants	1 Participants n=22 Participants
Region of Enrollment United States	23 participants n=9 Participants	22 participants n=27 Participants	—	—	—	—	12 participants n=23 Participants	57 participants n=22 Participants

PRIMARY outcome

Timeframe: Baseline visit

Population: Enrollment concluded early due to end of funding and covid-related delays. This outcome measure is not available for the last arm/group. Serum propofol levels were not obtained in that arm of the study. That arm of the study was specifically designed to assess neurophysiological/electrophyiological measures, not serum propofol levels. It is impossible to report a value for that arm, since such measurements were not made in that arm of the study for that particular outcome measure.

Average targeted serum dose of propofol at which 50% of patients had loss of behavioral responses

Outcome measures

Outcome measures
Measure	Parkinson's Disease Patients With DBS, no Stimulation n=23 Participants 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 n=22 Participants 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.
Propofol Dose Response Curve	1.54 ug/mL Standard Deviation .20	1.58 ug/mL Standard Deviation 0.29	—	—	—	—	—

PRIMARY outcome

Timeframe: baseline

Population: Early conclusion of enrollment due to covid-related delays and end of funding. Loss of awareness was evaluated in each enrolled participant at different propofol levels. These outcomes cannot be summarized as a mean or any other measure of central tendency. The only meaningful outcome to be reported here is number of participants that were assess for this basic human science study.

Number of participants with loss of at least 50% of behavioral responses at a targeted serum concentration of 1.5 ug/mL using the following three behavioral responses will be evaluated: (1) loss/recovery of spontaneous movement (i.e., loss and recovery of responsiveness) (2) loss/recovery of movement in response to stimuli (separately to clicks \[non-salient\] and verbal stimuli \[salient\]), and (3) loss/recovery of movement to command (verbal command with patient name with instruction to open their eyes, as proxy of loss/recovery of consciousness).

Outcome measures

Outcome measures
Measure	Parkinson's Disease Patients With DBS, no Stimulation n=23 Participants 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 n=22 Participants 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 n=12 Participants 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.
Behavioral Assessment of Propofol Induced Loss / Recovery of Consciousness and Responsiveness	13 Participants	16 Participants	0 Participants	0 Participants	0 Participants	0 Participants	12 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Only the last arm had relevant patient enrolled to study neurophysiological signals. The number reported represents the single peak frequency at which neurophysiological changes occurred, not an average or a measure of centralral tendency. Neurophysiological measures were not obtained in the first two arms of the study in which patients were enrolled.

Oscillatory frequency at which maximal power changes occur with inducing loss of consciousness, as measured using ECoG and Globus Pallidus internus / Globus Pallidus externus (GPi/GPe) LFP recordings during DBS implantation surgery with target-controlled infusion of propofol. This is not an average frequency but a single peak value based on population spectra at which maximal changes are noted. The number reported is not an average of peaks across patients, but the peak identified after integrating data across the population studied. There is no corresponding measure of dispersion or prevision based on the way the value is identified. Rather, it is a single peak value.

Outcome measures

Outcome measures
Measure	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 n=12 Participants 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.
Electrocorticogram (ECoG) and Pallidal Local Field Potential (LFP) Recordings	—	—	—	—	—	—	3 Hz

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Nader Pouratian

UT Southwestern Medical Center

Phone: 2146489320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place