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NCT Number: NCT06778135

Neocortical Microarchitecture of Executive Function

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.

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Daniel R Kramer, MD

PRINCIPAL_INVESTIGATOR

Pamela David Gerecht, Ph.D.

CONTACT

[email protected]

303-724-4134

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

brain electrode

Device

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

Primary outcomes

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

    Time frame: 20 minutes

Secondary outcomes

  1. Measure the neural population dimensionality in response to changing task parameters

    Time frame: 20 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Pamela David Gerecht, PhD

CONTACT

[email protected]

303-724-4134

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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