Cognitive DeficitNCT05251454
Studying the Effects of Brain Stimulation on Cognitive Control and Associated EEG in Human Subjects.
A study testing Brain Stimulation in people with Cognitive Deficit, run by University of Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cognitive Deficit
- What is being tested?
- Brain Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 30 Dec 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who are undergoing electroencephalographic (EEG) monitoring as part of a standard clinical procedure for the treatment of pharmacologically resistant epilepsy at University of Cincinnati Medical Center.
Who cannot join
- Patients who have cognitive or physical impairments that would limit their ability to participate in the cognitive testing will be excluded from the study. Other exclusions include adults unable to consent, non-English speaking patients, children age 17 and younger, pregnant women (note: pregnant women are not candidates for intracranial EEG monitoring), and prisoners.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Neural Population Model-based Characterization and Modulation of Neural Oscillations Underlying Cognitive Control in Healthy and Depressed/Anxious Human Subjects.
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.
Read the detailed 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.
- Conditions
- Cognitive Deficit
- Being tested
- Brain Stimulation
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain StimulationProcedure or surgery
Participants will receive brief electrical brain stimulation as they perform the study tasks. This will be linked to events occurring on screen and/or to specific changes in their brain activity. The stimulation parameters will be individualized for each participant, but will never exceed safe limits for charge density (30 µC/phase).
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | Participants will receive brief electrical brain stimulation as they perform the study tasks. This will be linked to events occurring on screen and/or to specific changes in their brain activity. The stimulation parameters will be individualized for each participant, but will never exceed safe limits for charge density (30 µC/phase). They will always be tested beforehand to ensure that they do not cause participants any discomfort or distress. Receives: Procedure: Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiology
We will record local field potential (LFP) data continuously from 100+ electrodes as participants perform cognitive tasks that measure cognitive control. The primary outcome will be how LFP changes in response to changes in cognitive control behavior. This includes multiple sub-measures, such as power at individual electrode sites and connectivity metrics between electrodes.
Measured: up to 1 week
Cognitive Task Performance
Every time a participant performs our cognitive tasks, we will record their response times and whether they responded correctly to a given task trial. These will be collected in blocks, where the optimal strategy changes block to block. We will analyze those responses according to mathematical models that describe different aspects of cognitive control.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start20 Jun 2022
- Primary completion30 Apr 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeficitStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishita Basu, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251454
- Sponsor's protocol ID
- SEEG_Stimulation
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neural Population Model-based Characterization and Modulation of Neural Oscillations Underlying Cognitive Control in Healthy and Depressed/Anxious Human Subjects.
- ClinicalTrials.gov ID
- NCT05251454
- Acronym / sponsor ID
- SEEG_Stimulation
- Conditions
- Cognitive Deficit
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Feb 2022 (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 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.
Detailed 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Procedure: Brain StimulationParticipants will receive brief electrical brain stimulation as they perform the study tasks. This will be linked to events occurring on screen and/or to specific changes in their brain activity. The stimulation parameters will be individualized for each participant, but will never exceed safe limits for charge density (30 µC/phase). They will always be tested beforehand to ensure that they do not cause participants any discomfort or distress. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who are undergoing electroencephalographic (EEG) monitoring as part of a standard clinical procedure for the treatment of pharmacologically resistant epilepsy at University of Cincinnati Medical Center.
Key exclusion criteria (1 listed)
- Patients who have cognitive or physical impairments that would limit their ability to participate in the cognitive testing will be excluded from the study. Other exclusions include adults unable to consent, non-English speaking patients, children age 17 and younger, pregnant women (note: pregnant women are not candidates for intracranial EEG monitoring), and prisoners.
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 |
|---|---|---|
| Brain StimulationParticipants will receive brief electrical brain stimulation as they perform the study tasks. This will be linked to events occurring on screen and/or to specific changes in their brain activity. The stimulation parameters will be individualized for each participant, but will never exceed safe limits for charge density (30 µC/phase). | Procedure or surgery | Electrical stimulation |
Primary outcome
Electrophysiology
Time frame: up to 1 week
We will record local field potential (LFP) data continuously from 100+ electrodes as participants perform cognitive tasks that measure cognitive control. The primary outcome will be how LFP changes in response to changes in cognitive control behavior. This includes multiple sub-measures, such as power at individual electrode sites and connectivity metrics between electrodes.
Cognitive Task Performance
Time frame: up to 1 week
Every time a participant performs our cognitive tasks, we will record their response times and whether they responded correctly to a given task trial. These will be collected in blocks, where the optimal strategy changes block to block. We will analyze those responses according to mathematical models that describe different aspects of cognitive control.
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 2 Sep 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Stimulation in people with Cognitive Deficit, run by University of Cincinnati 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiology (time frame: up to 1 week). The study lists 2 primary outcomes in all. 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 2 Sep 2026.