Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06778135 | RECRUITING | Parkinson Disease

Neocortical Microarchitecture of Executive Function
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.

Condition or disease

Parkinson Disease

Intervention/treatment

Temporary implatation of large-scale intracranial electrode.

brain electrode

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : DEVICE_FEASIBILITY
Official Title : Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology
Actual Study Start Date : 2025-07-25
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Neocortical Microarchitecture of Executive Function

Location Details

NCT06778135

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045