Clinical Trials Logo

Clinical Trial Summary

This is a basic neuroscience study of modulating brain oscillations involved in cognitive control. We will record brain signals and stimulate specific regions of the brain in human participants who are undergoing monitoring for epilepsy surgery. It is not a clinical trial for treating any disease.


Clinical Trial Description

Cognitive control is a central element of human cognition that is impaired in several psychiatric diseases. It is closely associated with brain regions that are prominently dysregulated in disease such as the dorsal anterior cingulate cortex (dACC), the dorso-lateral prefrontal cortex (dlPFC), the orbitofrontal cortex (OFC), and the amygdala. Linking cognitive control to specific neural substrates and circuit-level interactions is critical for understanding how control disruptions lead to neurological and psychiatric diseases. This is work that is best done in humans, and so we will study cognitive control using intracranial local field potential recordings in human epilepsy patients. We will study cognitive control in patients who are having electrodes implanted for pre-surgical localization of epileptic seizures. These patients have electrodes in many of the brain regions involved in cognitive control, which is a unique opportunity to record from the human brain at a network level. Participants will perform laboratory tasks that measure cognitive control while we record the brain's electrical activity. The goal of this research proposal is to characterize and model cortical oscillations underlying the conflict resolution aspect of cognitive control in the healthy and anxious/depressed mental states to inform design of neuromodulation interventions for restoration towards healthy mental states. We will take three complimentary approaches to achieve this goal. 1) Using intracranial EEG recorded in epilepsy patients undergoing invasive monitoring for surgical evaluation, we will determine cortical neural oscillations underlying cognitive control in the framework of a conflict task. We will also use this to differentiate between normal and depressed or anxious subjects. 2) We will use a neural population cortical model to simulate and characterize feasible neural mechanisms underlying dlPFC and temporal cortical oscillations observed during conflict processing. We will use a data driven approach for estimating relevant model parameters. 3) We will use the model calibrated to individual subjects to design a cortical electrical stimulation paradigm to modulate the simulated oscillations towards a desired healthy state. We will then validate our model by testing model predictions in 4 human subjects and determine if we can successfully change both neural signals as well as associated behavior. This is not a randomized controlled trial. All participants will receive brain recording, and all will receive stimulation once stimulation methods are set up. The randomization will be within subject: some blocks of the task will be performed under different conditions that emphasize different aspects of the control calculation. Some blocks will have brain stimulation, and some will not. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05251454
Study type Interventional
Source University of Cincinnati
Contact Ishita Basu, PhD
Phone 5135583991
Email basuia@ucmail.uc.edu
Status Recruiting
Phase N/A
Start date June 20, 2022
Completion date January 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Completed NCT03695614 - Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia N/A
Active, not recruiting NCT05879562 - Validation of a Digital Self-Administered Cognitive Screening Tool: MoCA-XpressO N/A
Completed NCT03286439 - Recovery After Medical or Surgical Treatment
Recruiting NCT04251624 - Investigating the Use of Goal Management Therapy in Improving Cognitive Functioning in Public Safety Personnel With PTSD N/A
Not yet recruiting NCT02763397 - Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease N/A
Recruiting NCT04051528 - Do Combinatorial Training Lead to Better Cognition and Daily Participation in TBI Persons With Cognitive Impairments N/A
Recruiting NCT03036319 - Patient-Centered NeuroRehabilitation (PCN) N/A
Completed NCT05063669 - Cognitive Intervention in Attention Deficit and Hyperactivity Disorder N/A
Completed NCT02964221 - Cognitive Changes After Major Joint Replacement N/A
Not yet recruiting NCT05605366 - Minocycline In Neurocognitive Outcomes - Sickle Cell Disease Phase 1
Completed NCT02214342 - Virtual Reality Based Balance Training in People With Mild Cognitive Impairment N/A
Terminated NCT03032471 - Swiss SOS MoCA - DCI Study
Recruiting NCT04456777 - Effect of Vortioxetine on Cognitive Symptoms in Patients With Schizophrenia Early Phase 1
Recruiting NCT04204239 - Validation Study SCOBES-AR
Withdrawn NCT04457271 - Goal Management Training in Individuals With PTSD N/A
Terminated NCT03034109 - Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits N/A
Recruiting NCT05802680 - Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation N/A
Active, not recruiting NCT02847403 - Long-acting Exenatide and Cognitive Decline in Dysglycemic Patients Phase 3
Withdrawn NCT04654130 - Neurofeedback Effectiveness Trial in PTSD N/A