- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06235970
Cognitive Enhancement Through Model-based and Individualized Neurostimulation
The goal of this clinical trial is to learn about the effects of transcranial electric stimulation on attentional control and brain dynamics in healthy adults. The main questions are:
Does stimulation affect how subjects exert attentional control? Do mathematical models predict brain activity changes in response to stimulation?
Participants will have electroencephalography (EEG) brain data recorded while:
They sit relaxed They receive stimulation, while relaxed They receive stimulation while completing computerized tasks to measure cognitive abilities ("cognitive tasks") They receive sham (ineffective) stimulation during cognitive tasks
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research is to compare the effects of different transcranial electrical stimulation (tES) protocols on both EEG and behavioral markers associated with attention and cognitive control. Both conventional tES protocols (tDCS, tACS) will be compared with customized stimulation waveforms derived from an individualized whole-brain neural model (MINDy), and with periods of sham or no-stimulation.
Non-invasive brain stimulation approaches hold great promise as an intervention to enhance cognitive and brain function in humans, both in clinically impaired and even healthy young adult populations. Transcranial electrical stimulation, known as tES, refers to a family of methods that utilize low-cost technologies and involve low-intensity currents which are safe for humans, and carry minimal risk of side effects or adverse events. Conventional approaches, which utilize fixed direct currents (tDCS) or alternating currents at a fixed oscillatory frequency (tACS), have been widely used as both a basic research tool and as a clinical intervention. However, current literature suggests that tES may be more effective when deployed with stimulation protocols that are: 1) personalized (i.e., respecting individual differences in brain anatomy and function); and 2) informed by an understanding of the mechanisms that govern brain network activation dynamics and interactions.
The investigators will use a single-group design in which 60 healthy young adults receive different stimulation protocols, (plus an additional 10-12 recruited during the initial pilot testing phase), randomized within-subject during either resting- state (Aims 1, 2) or cognitive task conditions (Aim 3), while brain activity is monitored with electroencephalography (EEG). During the EEG recording periods, stimulation epochs will be randomly intermixed with epochs of sham or no- stimulation, with participants masked to the condition. Additionally, conventional stimulation protocols (tDCS, tACS) will be compared with customized stimulation waveforms derived from an individualized whole-brain neural model.
The study will consist of two EEG+tES sessions each lasting approximately one hour, and occurring on separate days.
Outcomes will be assessed in terms of different EEG markers, including spectral power both at the stimulation site and at target brain networks associated with attention and cognitive control (frontoparietal [FPN] and default mode [DMN] networks). Behavioral performance will also be assessed on a well-established experimental task (AX-CPT) that manipulates attention and cognitive control demands, in terms of key accuracy and reaction time performance indices.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Todd Braver, PhD
- Phone Number: 3149354153
- Email: tbraver@wustl.edu
Study Contact Backup
- Name: Carol Cox
- Phone Number: 3147152714
- Email: ccox@wustl.edu
Study Locations
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-
Missouri
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Saint Louis, Missouri, United States, 63130
- Recruiting
- Washington University
-
Contact:
- Carol Cox
- Phone Number: 3147152714
- Email: ccox@wustl.edu
-
Contact:
- Todd Braver
- Phone Number: 314-935-5143
- Email: tbraver@wustl.edu
-
Principal Investigator:
- ShiNung Ching, PhD
-
Principal Investigator:
- Todd Braver, PhD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy younger adults (ages 18 to 45). Community-living men, women or non-binary, aged 18-45
Exclusion criteria:
- Taking psychotropic medication or medication with cognitive side effects
- Medical disorder that affects cognitive or motor function
- Past/present head injury associated with loss of consciousness or neurological sequelae
- Prior occurrence of seizure of any origin
- Skin conditions affecting the scalp
- Scalp tattoos
- Rashes, sores or open wounds on scalp or face
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device: Transcranial electrical stimulation (tES) including SHAM
healthy adults
|
Transcranial electrical stimulation, known as tES, refers to a family of devices that utilize low-cost technologies and involve low-intensity currents which are safe for humans, and carry minimal risk of side effects or adverse events.
Conventional approaches, which utilize fixed direct currents (tDCS) or alternating currents at a fixed oscillatory frequency (tACS), have been widely used as both a basic research tool and as a clinical intervention.
In the current project, we use a custom-built device that enables near real-time current modulation triggered digitally, via software control, to allow for stimulation protocols guided by whole-brain individualized neural modeling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EEG Markers
Time Frame: Assessed concurrently during each of two 1-hour experimental sessions
|
Spectral power at stimulation site and within target networks (frontoparietal, default mode): EEG oscillatory power in the beta frequency band over frontal electrodes and theta frequency power over midline electrodes during the delay and response periods, averaged over trial-types.
We will also measure the difference in posterior alpha power between the Acue and Bcue trials-types during the delay period.
|
Assessed concurrently during each of two 1-hour experimental sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive task accuracy
Time Frame: Assessed concurrently during each of two 1-hour experimental sessions
|
Percentage of correct responses in the BX and AY trial types for the during AX-CPT task
|
Assessed concurrently during each of two 1-hour experimental sessions
|
Cognitive task speed
Time Frame: Assessed concurrently during each of two 1-hour experimental sessions
|
Time taken by participants to respond in the BX and AY trial types for the AX-CPT task
|
Assessed concurrently during each of two 1-hour experimental sessions
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21MH132240 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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