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Recruiting NCT06778135

Neocortical Microarchitecture of Executive Function

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Temporary implatation of large-scale intracranial electrode., brain electrode.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 45 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology

Overview

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

  • Procedure Temporary 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.
  • Device brain electrode
    Show that Neuropixels can safely and effectively record from large populations of neurons.

Primary outcome measures

  • Measure the neural population representations of task parameters along, and within, the cortical layers. [Time frame: 20 minutes]
Secondary outcome measures (1)
  • Measure the neural population dimensionality in response to changing task parameters [Time frame: 20 minutes]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • University of Colorado — Aurora

Identifiers

NCT: NCT06778135 · 23-1858 · R61DC021924

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗