Clinical trial NCT04502550: Brain Networks and Consciousness
Official title: Subcortical-cortical Network Dynamics of Anesthesia and Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Loss of Consciousness
Parkinson Disease
Essential Tremor
Anesthesia
Keywords: general anesthesia
deep brain stimulation
basal ganglia
thalamus
sensorimotor cortex
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2020-08-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
* Clinical diagnosis of Parkinson's disease or essential tremor
* Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities

Exclusion Criteria:

* Patients with recent use (within one week) of anticoagulant or antiplatelet agent use
* Neurocognitive testing indicating amnestic cognitive deficits
* History of intolerance of propofol or medical indications to use an anesthetic other than propofol

Primary outcomes:
measure: Propofol dose response curve
timeFrame: baseline
measure: Behavioral assessment of propofol induced loss / recovery of consciousness and responsiveness
timeFrame: baseline
measure: Electrocorticogram (ECoG) and pallidal Local Field Potential (LFP) recordings
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Nader Pouratian
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Nader Pouratian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: