NCT Number: NCT07073391
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Christopher I. Petkov
Other
Laminar Circuit Motifs for Working Memory and Language Combinatorics: From Cells to Systems
Acronym: LamCircuits
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
