Brain Networks and Consciousness
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| ClinicalTrials.gov Identifier: NCT04502550 |
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Recruitment Status :
Recruiting
First Posted : August 6, 2020
Last Update Posted : January 13, 2023
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| Tracking Information | |||||||||
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| First Submitted Date | July 30, 2020 | ||||||||
| First Posted Date | August 6, 2020 | ||||||||
| Last Update Posted Date | January 13, 2023 | ||||||||
| Actual Study Start Date | October 15, 2020 | ||||||||
| Estimated Primary Completion Date | February 15, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Brain Networks and Consciousness | ||||||||
| Official Title | Subcortical-cortical Network Dynamics of Anesthesia and Consciousness | ||||||||
| Brief Summary | 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Study participants are Parkinson's disease and essential tremor patients undergoing revision/replacement of an implantable pulse generator for DBS, or initial DBS implantation. | ||||||||
| Condition |
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| Intervention | Drug: 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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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
144 | ||||||||
| Original Estimated Enrollment |
48 | ||||||||
| Estimated Study Completion Date | August 15, 2025 | ||||||||
| Estimated Primary Completion Date | February 15, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04502550 | ||||||||
| Other Study ID Numbers | STU-2021-0396 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Nader Pouratian, University of Texas Southwestern Medical Center | ||||||||
| Original Responsible Party | Nader Pouratian, University of California, Los Angeles, Principle Investigator | ||||||||
| Current Study Sponsor | University of Texas Southwestern Medical Center | ||||||||
| Original Study Sponsor | University of California, Los Angeles | ||||||||
| Collaborators | University of California, Los Angeles | ||||||||
| Investigators |
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| PRS Account | University of Texas Southwestern Medical Center | ||||||||
| Verification Date | January 2023 | ||||||||