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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04885322
Other study ID # 1344169-8
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 14, 2021
Est. completion date June 30, 2024

Study information

Verified date August 2023
Source University of California, Davis
Contact Minhtrang Chu
Phone 1-916-734-1482
Email mihchu@ucdavis.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial Direct Current Stimulation
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.

Locations

Country Name City State
United States Imaging Research Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Behavioral Attention Lapse Measures on the Change Detection Task Attention factor (a); Guess factor (g) Through study completion, an average of 1 month
Primary 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
Primary Delivered tDCS Dose to PFC Estimated electric field in PFC region of interest Through study completion, an average of 1 month
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