Recording neurons in the frontal cortex during awake DBS surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.