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Conclusion of funding
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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General anesthesia (GA) is a medically induced state of unresponsiveness and unconsciousness, which millions of people experience every year. Despite its ubiquity, a clear and consistent picture of the brain circuits mediating consciousness and responsiveness has not emerged. Studies to date are limited by lack of direct recordings in human brain during medically induced anesthesia. Our overall hypothesis is that the current model of consciousness, originally proposed to model disorders and recovery of consciousness after brain injury, can be generalized to understand mechanisms of consciousness more broadly. This will be studied through three specific aims. The first is to evaluate the difference in anesthesia sensitivity in patients with and without underlying basal ganglia pathology. Second is to correlate changes in brain circuitry with induction and emergence from anesthesia. The third aim is to evaluate the effects of targeted deep brain stimulation on anesthesia induced loss and recovery of consciousness. This study focuses on experimentally studying these related brain circuits by taking advantage of pathological differences in movement disorder patient populations undergoing deep brain stimulation (DBS) surgery. DBS is a neurosurgical procedure that is used as treatment for movement disorders, such as Parkinson's disease and essential tremor, and provides a mechanism to acquire brain activity recordings in subcortical structures. This study will provide important insight by using human data to shed light on the generalizability of the current model of consciousness. The subject's surgery for DBS will be prolonged by up to 40 minutes in order to record the participant's brain activity and their responses to verbal and auditory stimuli.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Propofol Dose Response Curve | Average targeted serum dose of propofol at which 50% of patients had loss of behavioral responses | Baseline visit |
| Behavioral Assessment of Propofol Induced Loss / Recovery of Consciousness and Responsiveness | 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). | baseline |
| Electrocorticogram (ECoG) and Pallidal Local Field Potential (LFP) Recordings | 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants are Parkinson's disease and essential tremor patients undergoing revision/replacement of an implantable pulse generator for DBS, or initial DBS implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Nader Pouratian, MD, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nader Pouratian | Dallas | Texas | 75235 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study completed before enrolling all originally planned participants due to end in funding.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Propofol Dose Response Curve | Average targeted serum dose of propofol at which 50% of patients had loss of behavioral responses | 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. | Posted | Mean | Standard Deviation | ug/mL | Baseline visit |
|
24 hours
We used clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nader Pouratian | UT Southwestern Medical Center | 2146489320 | nader.pouratian@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2021 | Feb 12, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF Part 2 | Sep 20, 2021 | Feb 12, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF Part 1 | Sep 20, 2021 | Feb 12, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
| Primary | Behavioral Assessment of Propofol Induced Loss / Recovery of Consciousness and Responsiveness | 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). | 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
|
| Primary | Electrocorticogram (ECoG) and Pallidal Local Field Potential (LFP) Recordings | 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. | 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. | Posted | Number | Hz | Baseline |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |