Neuronal MechanismsLamCircuitsNCT07073391
Clinical Study of How Information Flows Across the Human Cortical Sheet Layers (Laminae), Aiming to Discover Key Principles of Laminar Circuits and Information Flow for Complex Behavior.
A study testing Recording with laminar arrays in people with Neuronal Mechanisms and Laminar Circuits, run by Christopher I. Petkov.
Trial summary
This is a basic science study of a missing dimension of human brain function, how information flows the six layers of the brain. The research will involve neurosurgery patients and controls in laminar-resolution functional MRI at 7 Tesla during a working memory and language task. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuronal Mechanisms, Laminar Circuits
- What is being tested?
- Recording with laminar arrays
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Sep 2032
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients: Eligible for wake DBS implantation or epilepsy/tumor/biopsy treatment procedure, within the age range of 18 and 80 years old.
- Healthy controls: can only participate in the non-invasive brain imaging study, within the age range of 18 and 80 years old.
Who cannot join
- Psychiatric disorder
- Drug addiction
- Not able to conduct an English based language task
- Not capable of being scanned with MRI (e.g., metal implants)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Laminar Circuit Motifs for Working Memory and Language Combinatorics: From Cells to Systems
This is a basic science study of a missing dimension of human brain function, how information flows the six layers of the brain. The research will involve neurosurgery patients and controls in laminar-resolution functional MRI at 7 Tesla during a working memory and language task. The neurosurgery patients will be involved in intracranial recordings with FDA approved electrodes capable of recording across the cortical layers, or electrodes with FDA Investigational Device Exemption. The neurosurgery patients will also be able to provide tissue samples for genomics research from tissue that would be clinically removed, resected or disrupted as part of the clinical treatment. The outcome is unprecedented insights into this missing dimension of human brain function which will help to advance biomedical science and could be crucial for developing better patient diagnostic and treatment options for a host of brain disorders where laminar information flow is disrupted but currently cannot be effectively studied.
Read the detailed description
Humans are uniquely capable of combining information in novel ways to give meaning and infer unobservable causes in the environment. This ability is supported by interactions between working memory and sensory processes. When applied to language, these combinatorial processes give us the ability to reason and plan. This complex behavior is thought to be grounded in information flowing both forward and backward between cortical areas, routed through the six layered organization of the mammalian neocortex. Testing this hypothesis requires gathering information of human laminar circuits at multiple scales, from the molecular (informing the composition of local circuits) to the mesoscopic (detailing information flow within an area across laminae) and network (across areas) ones. This challenging objective has so far remained out of reach, investigating laminar circuits has been mostly confined to animal models, limiting our understanding of human complex behaviors. To break through, the investigators propose a partnership that can provide these much needed multiscale observations in 100+ neurosurgery patients and: 1) record both high-density (laminar) array recordings and subdural recordings from prefrontal and temporal cortical areas while patients conduct a task that requires the manipulation of linguistic information in working memory; 2) characterize the laminar cell-specific molecular and genetic properties of tissue sampled immediately after the recordings; and 3) scale laminar circuit insights to mesoscopic levels accessible with laminar fMRI at 7 Tesla, in the same patients undergoing electrophysiological recordings. By combining this information using a (generative) computational modeling approach, the investigators will unravel how local neural dynamics and forward and backward information passing across areas supports our ability to recombine linguistic information in working memory. The unique multiscale level information of human brain function that the investigators aim to collect will benefit efforts beyond the cognitive field, such as those oriented at understanding the biophysical processes underlying non-invasive recordings such as fMRI.
- Conditions
- Neuronal Mechanisms, Laminar Circuits
- Being tested
- Recording with laminar arrays
- Keywords
- laminar array recordings, single unit recordings, cortical layers, laminar fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording with laminar arraysDevice
Part of the intervention is reliant on FDA approved laminar recording electrodes already available in the US. The other part will be an investigational device that is currently being considered by the FDA for an Investigational Device Exclusion.
| Study group | Role | What they receive |
|---|---|---|
| Laminar Circuit Motif Observation Group | Experimental | Laminar Circuit Motif Observation Cohort Receives: Device: Recording with laminar arrays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of Laminar Circuit Motifs
The primary objective is whether and how laminar profiles deviate from baseline under the different observational conditions: laminar fMRI, laminar array recordings and with tissue sampling genomics. A score of 0 indicates no significant deviation therefore no laminar information flow. A significant profile will indicate information flow across the cortical layers with the profile identifying which layers are involved in information flow across the cortical layers. This primary outcome will be studied individually by patients and in the cohort as a group.
Measured: From enrollment to the end of the clinical study at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuronal MechanismsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher I. Petkov
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Christopher I. Petkov, University of Iowa
- Investigators
- Christopher Petkov, PhD, Study director, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073391
- Sponsor's protocol ID
- 202502101
- Other IDs
- U01NS137991
- Acronym
- LamCircuits
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laminar Circuit Motifs for Working Memory and Language Combinatorics: From Cells to Systems
- ClinicalTrials.gov ID
- NCT07073391
- Acronym / sponsor ID
- LamCircuits / 202502101
- Conditions
- Neuronal Mechanisms, Laminar Circuits
- Keywords
- laminar array recordings, single unit recordings, cortical layers, laminar fMRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Christopher I. PetkovUniversity, hospital or other
- Collaborators
- University of Minnesota, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2032 (estimated)
- First posted
- 18 Jul 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 is a basic science study of a missing dimension of human brain function, how information flows the six layers of the brain. The research will involve neurosurgery patients and controls in laminar-resolution functional MRI at 7 Tesla during a working memory and language task. The neurosurgery patients will be involved in intracranial recordings with FDA approved electrodes capable of recording across the cortical layers, or electrodes with FDA Investigational Device Exemption. The neurosurgery patients will also be able to provide tissue samples for genomics research from tissue that would be clinically removed, resected or disrupted as part of the clinical treatment. The outcome is unprecedented insights into this missing dimension of human brain function which will help to advance biomedical science and could be crucial for developing better patient diagnostic and treatment options for a host of brain disorders where laminar information flow is disrupted but currently cannot be effectively studied.
Detailed description
Humans are uniquely capable of combining information in novel ways to give meaning and infer unobservable causes in the environment. This ability is supported by interactions between working memory and sensory processes. When applied to language, these combinatorial processes give us the ability to reason and plan. This complex behavior is thought to be grounded in information flowing both forward and backward between cortical areas, routed through the six layered organization of the mammalian neocortex. Testing this hypothesis requires gathering information of human laminar circuits at multiple scales, from the molecular (informing the composition of local circuits) to the mesoscopic (detailing information flow within an area across laminae) and network (across areas) ones. This challenging objective has so far remained out of reach, investigating laminar circuits has been mostly confined to animal models, limiting our understanding of human complex behaviors. To break through, the investigators propose a partnership that can provide these much needed multiscale observations in 100+ neurosurgery patients and: 1) record both high-density (laminar) array recordings and subdural recordings from prefrontal and temporal cortical areas while patients conduct a task that requires the manipulation of linguistic information in working memory; 2) characterize the laminar cell-specific molecular and genetic properties of tissue sampled immediately after the recordings; and 3) scale laminar circuit insights to mesoscopic levels accessible with laminar fMRI at 7 Tesla, in the same patients undergoing electrophysiological recordings. By combining this information using a (generative) computational modeling approach, the investigators will unravel how local neural dynamics and forward and backward information passing across areas supports our ability to recombine linguistic information in working memory. The unique multiscale level information of human brain function that the investigators aim to collect will benefit efforts beyond the cognitive field, such as those oriented at understanding the biophysical processes underlying non-invasive recordings such as fMRI.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laminar Circuit Motif Observation Group | Experimental | Device: Recording with laminar arraysLaminar Circuit Motif Observation Cohort |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients: Eligible for wake DBS implantation or epilepsy/tumor/biopsy treatment procedure, within the age range of 18 and 80 years old.
- Healthy controls: can only participate in the non-invasive brain imaging study, within the age range of 18 and 80 years old.
Key exclusion criteria (4 listed)
- Psychiatric disorder
- Drug addiction
- Not able to conduct an English based language task
- Not capable of being scanned with MRI (e.g., metal implants)
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 |
|---|---|---|
| Recording with laminar arraysPart of the intervention is reliant on FDA approved laminar recording electrodes already available in the US. The other part will be an investigational device that is currently being considered by the FDA for an Investigational Device Exclusion. | Device | Laminar Circuit Motif Observation Group |
Primary outcome
Observation of Laminar Circuit Motifs
Time frame: From enrollment to the end of the clinical study at 5 years
The primary objective is whether and how laminar profiles deviate from baseline under the different observational conditions: laminar fMRI, laminar array recordings and with tissue sampling genomics. A score of 0 indicates no significant deviation therefore no laminar information flow. A significant profile will indicate information flow across the cortical layers with the profile identifying which layers are involved in information flow across the cortical layers. This primary outcome will be studied individually by patients and in the cohort as a group.
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Christopher Petkov, PhD study director
University of Iowa
Questions about this trial
What is this clinical trial studying?
A study testing Recording with laminar arrays in people with Neuronal Mechanisms and Laminar Circuits, run by Christopher I. Petkov.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Christopher I Petkov, Professor, Vice Chair for Research, PhD (3199363445, cipetkov@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of Laminar Circuit Motifs (time frame: From enrollment to the end of the clinical study at 5 years). 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 11 Sep 2026.