Neocortical Microarchitecture of Executive Function

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06778135
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Study Start: 2025-04
• Primary Completion: 2027-10
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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. 5. Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.

5. Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC.

6. Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake.

7. 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. Cognitive impairment or executive function deficits as determined by neuropsychological testing
5. Evidence of a clinically significant abnormality on preoperative imaging.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measure the neural population representations of task parameters along, and within, the cortical layers.	20 minutes

Secondary Outcome Measures

Name	Time	Method
Measure the neural population dimensionality in response to changing task parameters	20 minutes

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States