Neocortical Microarchitecture of Executive Function | NCT06778135

Studies
Neocortical Microarchitecture of Executive Function

NCT06778135

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

Sep 17, 2025Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

Temporary implatation of large-scale intracranial electrode.
brain electrode

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R61DC021924	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2025Actual

Primary Completion Date

Oct 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jan 10, 2025

First Submission Date that Met QC Criteria

Jan 10, 2025

First Posted Date

Jan 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 17, 2025Actual

Name	Class
National Institute on Deafness and Other Communication Disorders (NIDCD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implanted	Experimental		Procedure: Temporary implatation of large-scale intracranial electrode. Device: brain electrode

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Measure the neural population dimensionality in response to changing task parameters		20 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases