Recruiting

Neuropixels Probes

Sponsor:

University of Colorado, Denver

Code:

NCT06778135

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Temporary implatation of large-scale intracranial electrode.

brain electrode

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT06778135

Start date

Jul 25, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Implanted

Interventions

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.

brain electrode

Show that Neuropixels can safely and effectively record from large populations of neurons.

Primary outcome measure

  • Measure the neural population representations of task parameters along, and within, the cortical layers. [ Time Frame: 20 minutes ]

Central Contacts and Locations

Central contacts

Pamela David Gerecht, PhD

303-724-4134pamela.davidgerecht@cuanschutz.edu

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Pamela David Gerecht, Ph.D.

303-724-4134pamela.davidgerecht@cuanschutz.edu

Principal Investigator:

Daniel R Kramer, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-09-17.