RecruitingNot ApplicableNCT06778135

Neocortical Microarchitecture of Executive Function

Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology

Sponsor

University of Colorado, Denver

Enrollment

15 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Min Age: 45 YearsMax Age: 85 Years

Inclusion Criteria9

Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
Aged 45-85
Able to provide informed consent
Normal neuropsychiatric evaluation that includes tests of executive function demonstrating no greater than mild impairments, within expectation for Parkinson's disease.
Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.
Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC.
Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake.
Able to tolerate 25 additional minutes of awake surgery.
Able to participate and comply with tasks adequately, including instructions provided in English.

Exclusion Criteria5

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

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Interventions

PROCEDURETemporary implatation of large-scale intracranial electrode.

The Neuropixels probe (imec, Leuven, Belgium) is a new high resolution multi electrode technology that uses custom 130-nm complementary metal-oxide-semiconductor fabrication with high surface area but low-impedance titanium nitride recordings to produce high site count devices with extreme electrode density in a small package.

DEVICEbrain electrode

Show that Neuropixels can safely and effectively record from large populations of neurons.