Neocortical Microarchitecture of Executive Function

Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Temporary implatation of large-scale intracranial electrode.; Device: brain electrode

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pamela David Gerecht, PhD; Phone Number: 303-724-4134; Email: pamela.davidgerecht@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Pamela David Gerecht, Ph.D.; Phone Number: 303-724-4134; Email: pamela.davidgerecht@cuanschutz.edu
      • Principal Investigator: Daniel R Kramer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 demonstrating no greater than mild impairments, within expectation for Parkinson's disease.
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. Moderate or severe cognitive impairment or executive function deficits as determined by neuropsychological testing.
5. Evidence of a clinically significant abnormality on preoperative imaging.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Implanted

Procedure: Temporary 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.; Device: brain electrode; Show that Neuropixels can safely and effectively record from large populations of neurons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the neural population representations of task parameters along, and within, the cortical layers.	20 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure the neural population dimensionality in response to changing task parameters	20 minutes

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 23-1858; R61DC021924 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No