Recording neurons in the frontal cortex during awake DBS surgery
Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology
This will try using Neuropixels probes to record hundreds of neurons in people with Parkinson's disease who are having awake deep brain stimulation surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06778135 on ClinicalTrials.gov |
What this trial studies
The project uses Neuropixels probes temporarily inserted into the middle frontal gyrus (mid-dlPFC, Brodmann area 9/46) during awake DBS procedures to record large populations of neurons. Recordings will capture layer-specific activity while participants perform tasks probing executive function and cognitive flexibility. The probe is placed and removed within the existing surgical procedure, adding about 25 minutes of awake time, and only patients who meet cognitive and surgical safety criteria are enrolled. Data will be analyzed to test whether neural population geometry and inter-layer interactions encode cognitive flexibility in humans.
Who should consider this trial
Good fit: People aged 45–85 with Parkinson's disease who are medically cleared for awake DBS, have no more than mild cognitive impairment, can tolerate an extra 25 minutes of awake surgery, and can follow instructions in English.
Not a fit: Patients with moderate-to-severe cognitive impairment, who cannot tolerate awake surgery, or whose surgical plan cannot safely access the dorsal lateral prefrontal cortex are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could improve understanding of frontal cortex circuits that support executive function and help guide future DBS targeting or therapies for cognitive symptoms in Parkinson's disease.
How similar studies have performed: This approach is largely novel in humans: large-scale Neuropixels recordings have been successful in animal studies and limited human pilot work, but broad human application remains untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Pamela David Gerecht, PhD
- Email: pamela.davidgerecht@cuanschutz.edu
- Phone: 303-724-4134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.