SchizophreniaNCT05053451
Brain Stimulation, Clinical Symptoms and Cognition
A study testing Transcranial Direct Current Stimulation in people with Schizophrenia, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Imaging Research Center
Sacramento, California, 95817
About this study
Official title: 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.
- Conditions
- Schizophrenia
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- schizophrenia, EEG, tDCS, dorsolateral prefrontal cortex, temporoparietal junction, cognitive control, auditory hallucinations, transcranial direct current stimulation
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| dlPFC/TPJ Stimulation + Rest | Experimental | 20 minutes of 2 mA direct current stimulation during rest. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start14 Sep 2021
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053451
- Sponsor's protocol ID
- 1607658
- Status last verified
- Apr 2023
- First submitted
- 2 Sep 2021
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) Studies of Auditory Hallucinations, Negative Symptoms and Cognition in Schizophrenia
- ClinicalTrials.gov ID
- NCT05053451
- Acronym / sponsor ID
- 1607658
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, EEG, tDCS, dorsolateral prefrontal cortex, temporoparietal junction, cognitive control, auditory hallucinations, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dlPFC/TPJ Stimulation + Rest | Experimental | Device: Transcranial Direct Current Stimulation20 minutes of 2 mA direct current stimulation during rest. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationIn 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. | Device | dlPFC/TPJ Stimulation + Rest |
Primary outcome
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Schizophrenia, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.