Back to resultsBrain Stimulation, Clinical Symptoms and Cognition
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, EEG, tDCS, dorsolateral prefrontal cortex, temporoparietal junction, cognitive control, auditory hallucinations, transcranial direct current stimulation
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.
- No children under the age of 18 will be recruited.
- Diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
- 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
Sites / Locations
- Imaging Research CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dlPFC/TPJ Stimulation + Rest
Arm Description
20 minutes of 2 mA direct current stimulation during rest.
Outcomes
Primary Outcome Measures
Change in Symptom Severity of Auditory Hallucinations
Participants will undergo diagnostic (clinical) interviews to rate their symptom severity using measures including, but not limited to, the Brief Psychiatric Rating Scale (rated 1-7, with a high rating indicating more severe symptoms), the Scale of the Assessment of Positive Symptoms (rated 0-5, with a high rating indicating more severe symptoms), and the Scale for the Assessment or Negative Symptoms (rated 0-5, with a high rating indicating more severe symptoms).
Change in Symptom Severity of Negative Symptoms
Participants will undergo diagnostic (clinical) interviews to rate their symptom severity using measures including, but not limited to, the Brief Psychiatric Rating Scale (rated 1-7, with a high rating indicating more severe symptoms), the Scale of the Assessment of Positive Symptoms (rated 0-5, with a high rating indicating more severe symptoms), and the Scale for the Assessment or Negative Symptoms (rated 0-5, with a high rating indicating more severe symptoms).
Secondary Outcome Measures
Full Information
NCT ID
NCT05053451
First Posted
September 2, 2021
Last Updated
April 16, 2023
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT05053451
Brief Title
Brain Stimulation, Clinical Symptoms and Cognition
Official Title
Transcranial Direct Current Stimulation (tDCS) Studies of Auditory Hallucinations, Negative Symptoms and Cognition in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the impact of non-invasive brain stimulation, transcranial direct current stimulation (tDCS), on auditory hallucinations, negative symptoms and cognition in schizophrenia. Clinical measures will be used to assess clinical symptoms and cognitive performance to test the hypothesis that a course of tDCS can reduce auditory hallucinations and negative symptoms in 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, temporoparietal junction, cognitive control, auditory hallucinations, transcranial direct current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dlPFC/TPJ Stimulation + Rest
Arm Type
Experimental
Arm Description
20 minutes of 2 mA direct current stimulation during rest.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
In tDCS, saline-soaked electrodes are temporarily 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, TPJ, Occipital Cortex) depending on the phase of the study.
Primary Outcome Measure Information:
Title
Change in Symptom Severity of Auditory Hallucinations
Description
Participants will undergo diagnostic (clinical) interviews to rate their symptom severity using measures including, but not limited to, the Brief Psychiatric Rating Scale (rated 1-7, with a high rating indicating more severe symptoms), the Scale of the Assessment of Positive Symptoms (rated 0-5, with a high rating indicating more severe symptoms), and the Scale for the Assessment or Negative Symptoms (rated 0-5, with a high rating indicating more severe symptoms).
Time Frame
Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
Title
Change in Symptom Severity of Negative Symptoms
Description
Participants will undergo diagnostic (clinical) interviews to rate their symptom severity using measures including, but not limited to, the Brief Psychiatric Rating Scale (rated 1-7, with a high rating indicating more severe symptoms), the Scale of the Assessment of Positive Symptoms (rated 0-5, with a high rating indicating more severe symptoms), and the Scale for the Assessment or Negative Symptoms (rated 0-5, with a high rating indicating more severe symptoms).
Time Frame
Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 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.
No children under the age of 18 will be recruited.
Diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
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
Emily Kasprick
Phone
916-734-8779
Email
eakasprick@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
Vanessa Zarubin
Phone
916-734-3749
Email
vczarubin@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).
Learn more about this trial
Brain Stimulation, Clinical Symptoms and Cognition
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