Who is eligible for clinical trial NCT06778135?

Participants must meet protocol criteria for Parkinson Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06778135 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-16

Neocortical Microarchitecture of Executive Function (NCT06778135)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of Colorado, Denver

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (6 items).

Location: University of Colorado — Aurora, Colorado

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Colorado — Aurora, Colorado

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗