Parkinson DiseaseNCT06778135
Neocortical Microarchitecture of Executive Function
A study testing Temporary implatation of large-scale intracranial electrode. and brain electrode in people with Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Temporary implatation of large-scale intracranial electrode. and brain electrode
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Pamela David Gerecht, Ph.D., 303-724-4134, pamela.davidgerecht@cuanschutz.edu
Daniel R Kramer, MD
About this study
Official title: Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Temporary implatation of large-scale intracranial electrode., brain electrode
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary implatation of large-scale intracranial electrode.Procedure or surgery
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 electrodeDevice
Show that Neuropixels can safely and effectively record from large populations of neurons.
| Study group | Role | What they receive |
|---|---|---|
| Implanted | Experimental | Not described Receives: Procedure: Temporary implatation of large-scale intracranial electrode.; Device: brain electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the neural population representations of task parameters along, and within, the cortical layers.
Measured: 20 minutes
Secondary outcomes (1)
Measure the neural population dimensionality in response to changing task parameters
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start25 Jul 2025
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778135
- Sponsor's protocol ID
- 23-1858
- Other IDs
- R61DC021924
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology
- ClinicalTrials.gov ID
- NCT06778135
- Acronym / sponsor ID
- 23-1858
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted | Experimental | Procedure: Temporary implatation of large-scale intracranial electrode., Device: brain electrode |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Implanted |
| brain electrodeShow that Neuropixels can safely and effectively record from large populations of neurons. | Device | Implanted |
Primary outcome
Measure the neural population representations of task parameters along, and within, the cortical layers.
Time frame: 20 minutes
1 secondary outcome
Measure the neural population dimensionality in response to changing task parameters
Time frame: 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary implatation of large-scale intracranial electrode. and brain electrode in people with Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela David Gerecht, PhD (303-724-4134, pamela.davidgerecht@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the neural population representations of task parameters along, and within, the cortical layers. (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.