Neocortical Microarchitecture of Executive Function

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06778135

23-1858

R61DC021924 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Implanted

Experimental group

Treatment:

Device: brain electrode

Procedure: Temporary implatation of large-scale intracranial electrode.