Skip to content

Neocortical Microarchitecture of Executive Function

Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06778135
Enrollment
15
Registered
2025-01-16
Start date
2025-07-25
Completion date
2027-12-31
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

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.

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Measure the neural population representations of task parameters along, and within, the cortical layers.20 minutes

Secondary

MeasureTime frame
Measure the neural population dimensionality in response to changing task parameters20 minutes

Countries

United States

Contacts

Primary ContactPamela David Gerecht, PhD
pamela.davidgerecht@cuanschutz.edu303-724-4134

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026