- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05053451
Brain Stimulation, Clinical Symptoms and Cognition
April 16, 2023 updated by: University of California, Davis
Transcranial Direct Current Stimulation (tDCS) Studies of Auditory Hallucinations, Negative Symptoms and Cognition in Schizophrenia
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emily Kasprick
- Phone Number: 916-734-8779
- Email: eakasprick@ucdavis.edu
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- Recruiting
- Imaging Research Center
-
Contact:
- Vanessa Zarubin
- Phone Number: 916-734-3749
- Email: vczarubin@ucdavis.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dlPFC/TPJ Stimulation + Rest
20 minutes of 2 mA direct current stimulation during rest.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Symptom Severity of Auditory Hallucinations
Time Frame: Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
|
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).
|
Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
|
Change in Symptom Severity of Negative Symptoms
Time Frame: Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
|
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).
|
Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2021
Primary Completion (Anticipated)
February 29, 2024
Study Completion (Anticipated)
August 31, 2024
Study Registration Dates
First Submitted
September 2, 2021
First Submitted That Met QC Criteria
September 13, 2021
First Posted (Actual)
September 22, 2021
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 16, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1607658
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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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