Neocortical Microarchitecture of Executive Function

NCT06778135 | Recruiting DMC FDA Device

• 2 other identifiers: 23-1858R61DC021924
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Measure the neural population representations of task parameters along, and within, the cortical layers.

  20 minutes

Secondary Outcomes (1)

• Measure the neural population dimensionality in response to changing task parameters

  20 minutes

Study Arms (1)

Implanted

EXPERIMENTAL

Procedure: Temporary implatation of large-scale intracranial electrode.; Device: brain electrode

Interventions

Temporary implatation of large-scale intracranial electrode. 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.

Implanted

brain electrode DEVICE

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

Implanted

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Pamela David Gerecht, PhD

CONTACT

303-724-4134; pamela.davidgerecht@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)