Studying the Effects of Brain Stimulation on Cognitive Control and Associated EEG in Human Subjects.

NCT05251454 | Active Not Recruiting

• 1 other identifier: SEEG_Stimulation
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Deficit

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  up to 1 week

Study Arms (1)

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.

Procedure: Brain Stimulation

Interventions

Brain Stimulation PROCEDURE

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).

Electrical stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Cognition Disorders

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 22, 2022
• Study Start: June 20, 2022
• Primary Completion: April 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

US (1)