- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885322
Effects of PFC tDCS on Cognitive Control, Attention Lapses and Coordinated Neural Activity in the Theta and Alpha Bands
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Minhtrang Chu
- Phone Number: 1-916-734-1482
- Email: mihchu@ucdavis.edu
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- Recruiting
- Imaging Research Center
-
Contact:
- Vanessa Zarubin, BS/BA
- Phone Number: 916-734-3749
- Email: vczarubin@ucdavis.edu
-
Principal Investigator:
- Cameron Carter, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DLPFC Stimulation
Intervention.
20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex.
|
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.
|
|
Experimental: Occipital Stimulation
Intervention.
20 minutes of 2 mA direct current stimulation over the occipital cortex.
|
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.
|
|
Sham Comparator: Sham Stimulation
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral Cognitive Control Measures on the Stroop Task
Time Frame: Through study completion, an average of 1 month
|
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
Time Frame: Through study completion, an average of 1 month
|
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
Time Frame: Through study completion, an average of 1 month
|
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
Time Frame: Through study completion, an average of 1 month
|
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
Time Frame: Through study completion, an average of 1 month
|
WM storage capacity (k-max)
|
Through study completion, an average of 1 month
|
|
EEG Cognitive Control Measures on the Change Detection Task
Time Frame: Through study completion, an average of 1 month
|
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
Time Frame: Through study completion, an average of 1 month
|
Attention factor (a); Guess factor (g)
|
Through study completion, an average of 1 month
|
|
EEG Attention Lapse Measures on the Change Detection Task
Time Frame: Through study completion, an average of 1 month
|
Pre-trial power in the alpha frequency band (8-12 Hz)
|
Through study completion, an average of 1 month
|
|
Delivered tDCS Dose to PFC
Time Frame: Through study completion, an average of 1 month
|
Estimated electric field in PFC region of interest
|
Through study completion, an average of 1 month
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1344169-8
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
product manufactured in and exported from the U.S.
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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