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Effects of Brain Stimulation on Higher-Order Cognition

Primary Purpose

Schizophrenia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring schizophrenia, EEG, tDCS, dorsolateral prefrontal cortex, cognitive control, language, transcranial direct current stimulation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participants must be able to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks.
All subjects must have the ability to give valid informed consent.

Inclusion Criteria for Patients with Schizophrenia Only:

Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
No medication changes in the prior month
No medication changes anticipated in the upcoming month
Stable outpatient or partial hospital status
Normal IQ (>70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test)
Must not be currently taking the antipsychotic clozapine

Exclusion Criteria:

Pacemakers
Implanted electrical (brain and spinal) stimulators
Implanted defibrillator
Metallic implants
Skin damage or skin conditions such as eczema at the sites where electrodes will be placed
Hair styles hindering the placement of electrodes
Cranial pathologies
Head trauma
Epilepsy
Mental retardation
Any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, cerebral palsy, any DSM-5 axis I psychiatric disorder (for healthy control subjects), autism)
Uncorrected vision problems that would hinder cognitive testing (this also pertains to subjects with color blindness in tasks where discriminating colored objects/items is necessary for successful performance)
Pregnancy
Substance dependence in the past six months
Substance abuse in the past month

Sites / Locations

Imaging Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

DLPFC Stimulation

Occipital Stimulation

Sham Stimulation

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

EEG Correlates of Language and Cognitive Control

Electrophysiological data recorded during completion of cognitive control and language comprehension tasks. We will measure oscillatory activity in the theta, alpha, beta and gamma frequency bands.

Behavioral Response (Cognitive Control Task)

We will assess performance on the Dot Pattern Expectancy (DPX) task (error rates and d-prime scores).

Behavioral Response (Language Task)

We will assess performance on a novel Language Comprehension task (accuracy and semantic relatedness judgement scores).

Secondary Outcome Measures

Full Information

NCT ID

NCT03814967

First Posted

January 15, 2019

Last Updated

September 14, 2023

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT03814967

Brief Title

Effects of Brain Stimulation on Higher-Order Cognition

Official Title

Transcranial Direct Current Stimulation (tDCS) Studies of Behavioral and Electrophysiological (EEG) Correlates of Higher-Order Cognition

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 22, 2019 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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. The investigator's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

schizophrenia, EEG, tDCS, dorsolateral prefrontal cortex, cognitive control, language, transcranial direct current stimulation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DLPFC Stimulation

Arm Type

Experimental

Arm Description

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

Arm Title

Occipital Stimulation

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham Stimulation

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation

Intervention Description

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 (e.g. the DLPFC). To control for placebo effects, the study will utilize a sham stimulation protocol that consists of very brief constant stimulation (~1 minute). Subjects usually cannot discern the difference between the sham and experimental stimulation protocols due to habituation.

Primary Outcome Measure Information:

Title

EEG Correlates of Language and Cognitive Control

Description

Electrophysiological data recorded during completion of cognitive control and language comprehension tasks. We will measure oscillatory activity in the theta, alpha, beta and gamma frequency bands.

Time Frame

Assessment will begin immediately following stimulation and last for about 1.5 hours.

Title

Behavioral Response (Cognitive Control Task)

Description

We will assess performance on the Dot Pattern Expectancy (DPX) task (error rates and d-prime scores).

Time Frame

Assessment will begin immediately following stimulation and last for about 1.5 hours.

Title

Behavioral Response (Language Task)

Description

We will assess performance on a novel Language Comprehension task (accuracy and semantic relatedness judgement scores).

Time Frame

Assessment will begin immediately following stimulation and last for about 1.5 hours.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must be able to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks. All subjects must have the ability to give valid informed consent. Inclusion Criteria for Patients with Schizophrenia Only: Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder No medication changes in the prior month No medication changes anticipated in the upcoming month Stable outpatient or partial hospital status Normal IQ (>70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test) Exclusion Criteria: Pacemakers Implanted electrical (brain and spinal) stimulators Implanted defibrillator Metallic implants Skin damage or skin conditions such as eczema at the sites where electrodes will be placed Hair styles hindering the placement of electrodes Cranial pathologies Head trauma Epilepsy Mental retardation Any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, cerebral palsy, any DSM-5 axis I psychiatric disorder (for healthy control subjects), autism) Uncorrected vision problems that would hinder cognitive testing (this also pertains to subjects with color blindness in tasks where discriminating colored objects/items is necessary for successful performance) Pregnancy Substance dependence in the past six months Substance abuse in the past month

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Megan A Boudewyn, Ph.D.

Phone

831-459-5084

mboudewyn@ucsc.edu

Facility Information:

Facility Name

Imaging Research Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Minhtrang Chu, BS

Phone

916-734-1482

mihchu@ucdavis.edu

First Name & Middle Initial & Last Name & Degree

Cameron Carter, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Select data from this study may be submitted to the National Institute of Mental Health Data Archive (NDA). NDA is a data repository run by the National Institute of Mental Health (NIMH) that allows researchers studying mental illness to collect and share de-identified information with each other. The data repository is accessible only to qualified investigators. All subject data will be de-identified (subject names will not be used) and each subject will have a separate identifier called a Global Unique Identifier (GUID) to remove any possibility that "the identities of the subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users." (45 CFR, 46.102).

Links:

URL

https://studypages.com/s/a-study-of-the-effects-of-brain-stimulation-on-higher-order-cognition-761403/

Description

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Effects of Brain Stimulation on Higher-Order Cognition

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