Clinical trial NCT06778135: Neocortical Microarchitecture of Executive Function
Official title: Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2025-01-16
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is being done to the determine the ability and utility of using the Neuropixels probes in the human brain. A Neuropixels probe will be inserted into and removed from the brain of awake human patients who are undergoing awake Deep Brain Stimulation (DBS) surgery.

Detailed description: This project aims to use Neuropixels probes to record hundreds of neurons during awake human intracranial surgeries. Using this probe, we will take advantage of access to a key area in the network involved in executive function, the middle frontal gyrus of the dorsal lateral Pre Frontal Cortex (approximately the mid portion of dlPFC, part of Brodmann area 9/46), to test emerging concepts that cognitive flexibility so crucial to human EF is encoded in neural population geometry and layer-specific interactions.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
2. Aged 45-85
3. Able to provide informed consent
4. Normal neuropsychiatric evaluation that includes tests of executive function. 5. Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.

6. Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC.

7. Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake.

8. Able to tolerate 25 additional minutes of awake surgery. 9. Able to participate and comply with tasks adequately, including instructions provided in English.

Exclusion Criteria:

1. Moderate, or severe cognitive impairment as determined by a licensed neuropsychologist during routine neuropsychological evaluation.
2. Inability to tolerate awake surgery as determined by the treating neurologist and study neurosurgeon.
3. Inability to safely access the dorsal lateral prefrontal cortex for an entry location.
4. Cognitive impairment or executive function deficits as determined by neuropsychological testing
5. Evidence of a clinically significant abnormality on preoperative imaging.

Primary outcomes:
measure: Measure the neural population representations of task parameters along, and within, the cortical layers.
timeFrame: 20 minutes
Secondary outcomes:
measure: Measure the neural population dimensionality in response to changing task parameters
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
References: