Neocortical Microarchitecture of Executive Function

NCT ID: NCT06778135

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2027-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Implanted

Group Type: EXPERIMENTAL

Temporary implatation of large-scale intracranial electrode.

Intervention Type: PROCEDURE

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.

brain electrode

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: PROCEDURE

brain electrode

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

Intervention Type: DEVICE

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 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamela David Gerecht, PhD

Role: CONTACT

pamela.davidgerecht@cuanschutz.edu

303-724-4134

Facility Contacts

Pamela David Gerecht, Ph.D.

Role: primary

pamela.davidgerecht@cuanschutz.edu

303-724-4134

Other Identifiers

R61DC021924

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-1858

Identifier Type: -

Identifier Source: org_study_id