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Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 47 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 4

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

Arm Label

DLPFC Stimulation + Task

DLPFC Stimulation + Rest

Sham Stimulation + Task

Sham Stimulation + Rest

Arm Description

Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during cognitive task completion.

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

Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during cognitive task completion.

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

Outcomes

Primary Outcome Measures

EEG Correlates of Language and Cognitive Control
Electrophysiological data recorded during completion of cognitive control tasks. We will measure oscillatory activity from 3-80 Hz.
Behavioral Response
We will assess performance on the Dot Pattern Expectancy (DPX) task (error rates).
Behavioral Response
We will assess performance on the Dot Pattern Expectancy (DPX) task (d-prime scores).

Secondary Outcome Measures

Full Information

First Posted
February 3, 2020
Last Updated
July 21, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04267003
Brief Title
Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in Schizophrenia
Official Title
Transcranial Direct Current Stimulation (tDCS) Studies of Cognition, Oscillations and GABA Levels in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
August 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
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
People with schizophrenia often have problems with attention, learning and memory and other cognitive abilities that interfere with their work and school performance. Unfortunately, even our best treatments often do not significantly reduce these cognitive problems. The current study investigates whether or not delivering a very small electrical current to people's foreheads (called, transcranial direct current stimulation; (tDCS)) might improve functioning in the front part of the brain and reduce these cognitive problems in people with schizophrenia. tDCS is non-invasive and has been shown to improve cognitive functioning in some preliminary studies. The current study will investigate whether giving tDCS during a task is more effective than giving it during rest (Aim 1), whether delivery of tDCS to the front of the head is more effective than delivery to the back of the head (Aim 2), and whether tDCS delivery will alter levels of a major inhibitory neurotransmitter in the brain (GABA; Aim 3) that is important to cognitive functioning and may be disrupted in people with schizophrenia. Although this study is not intended to diagnose, cure or treat schizophrenia or any other disease, if results are positive it will encourage future large-scale studies to determine if tDCS can become an effective treatment for cognitive problems in people with schizophrenia.

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, transcranial direct current stimulation, GABA, MR spectroscopy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DLPFC Stimulation + Task
Arm Type
Experimental
Arm Description
Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during cognitive task completion.
Arm Title
DLPFC Stimulation + Rest
Arm Type
Experimental
Arm Description
Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during rest.
Arm Title
Sham Stimulation + Task
Arm Type
Sham Comparator
Arm Description
Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during cognitive task completion.
Arm Title
Sham Stimulation + Rest
Arm Type
Sham Comparator
Arm Description
Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during rest.
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 tasks. We will measure oscillatory activity from 3-80 Hz.
Time Frame
Assessment will begin immediately following stimulation and last for about 1.5 hours.
Title
Behavioral Response
Description
We will assess performance on the Dot Pattern Expectancy (DPX) task (error rates).
Time Frame
Assessment will begin immediately following stimulation and last for about 1.5 hours.
Title
Behavioral Response
Description
We will assess performance on the Dot Pattern Expectancy (DPX) task (d-prime 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
47 Years
Accepts Healthy Volunteers
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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Molly A Bainbridge
Phone
(916) 734-8779
Email
mebainbridge@ucdavis.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
Molly Bainbridge
Phone
916-734-3749
Email
mebainbridge@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/effects-of-brain-stimulation-on-cognition-oscillations-and-gaba-levels-in-schizophrenia-205153/
Description
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Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in Schizophrenia

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