NCT04885322

Brief Summary

The purpose of this study is to better understand the neural correlates of higher-order cognition, both in the healthy brain and in schizophrenia, and to determine how these mechanisms are modulated by transcranial direct current stimulation (tDCS) at frontal and occipital scalp sites. Testing the effects of tDCS at these scalp sites on cognitive task performance will help us understand the roles of the brain regions corresponding to these sites during higher-order cognitive processing (language comprehension, cognitive control, and related attention and memory processes). Behavioral and electrophysiological (EEG) measures will be used to assess cognitive performance. Our overarching hypothesis is that stimulating prefrontal circuits with tDCS can improve cognitive control performance, and ultimately performance on a range of cognitive tasks, as compared to stimulating a different cortical region (occipital cortex) or using sham stimulation. This study is solely intended as basic research in order to understand brain function in healthy individuals and individuals with schizophrenia. This study is not intended to diagnose, cure or treat schizophrenia or any other disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for not_applicable healthy

Timeline
14mo left

Started Apr 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Apr 2021Jun 2027

Study Start

First participant enrolled

April 14, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

6.2 years

First QC Date

May 4, 2021

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • Behavioral Cognitive Control Measures on the Stroop Task

    Incongruent versus Congruent difference in error rate and reaction time

    Through study completion, an average of 1 month

  • EEG Cognitive Control Measures on the Stroop Task

    response-locked power in the theta frequency band (4-7 Hz)

    Through study completion, an average of 1 month

  • Behavioral Attention Lapse Measures on the Stroop Task

    Error Rate on Incorrect Congruent trials (Full Lapses) and Slow-but-Correct Congruent trials (Partial Lapses)

    Through study completion, an average of 1 month

  • EEG Attention Lapse Measures on the Stroop Task EEG Attention Lapse Measures on the Stroop Task

    Pre-trial power in the alpha frequency band (8-12 Hz)

    Through study completion, an average of 1 month

  • Behavioral Cognitive Control Measures on the Change Detection Task Behavioral Cognitive Control Measures on the Change Detection Task

    WM storage capacity (k-max)

    Through study completion, an average of 1 month

  • EEG Cognitive Control Measures on the Change Detection Task

    delay period power in the theta frequency band (4-7 Hz)

    Through study completion, an average of 1 month

  • Behavioral Attention Lapse Measures on the Change Detection Task

    Attention factor (a); Guess factor (g)

    Through study completion, an average of 1 month

  • EEG Attention Lapse Measures on the Change Detection Task

    Pre-trial power in the alpha frequency band (8-12 Hz)

    Through study completion, an average of 1 month

  • Delivered tDCS Dose to PFC

    Estimated electric field in PFC region of interest

    Through study completion, an average of 1 month

Study Arms (3)

DLPFC Stimulation

EXPERIMENTAL

Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex.

Device: Transcranial Direct Current Stimulation

Occipital Stimulation

EXPERIMENTAL

Intervention. 20 minutes of 2 mA direct current stimulation over the occipital cortex.

Device: Transcranial Direct Current Stimulation

Sham Stimulation

SHAM COMPARATOR

Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation

Device: Transcranial Direct Current Stimulation

Interventions

In tDCS, saline-soaked electrodes are temporary affixed to the scalp and connected to a battery-powered current generator. A weak (2 mA) constant current is then briefly applied (\~20 minutes) to stimulate the targeted brain area. The targeted brain area is determined by the Study Arm.

DLPFC StimulationOccipital StimulationSham Stimulation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between ages of 18 and 50
  • ability to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks
  • ability to give valid informed consent

You may not qualify if:

  • no history of head trauma
  • no current or previous history of treatment with psychotropic medication
  • corrected vision 20/30 or better
  • tDCS/MRI contraindications, including: pregnancy, ferrous metal in any part of the body, serious medical conditions, claustrophobia, metallic implants, skin damage, conditions such as eczema at electrode sites, cranial pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imaging Research Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 13, 2021

Study Start

April 14, 2021

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations