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Trial registered on ANZCTR
Registration number
ACTRN12611000731998
Ethics application status
Approved
Date submitted
6/04/2010
Date registered
13/07/2011
Date last updated
9/06/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Transcranial Direct Current Stimulation (tDCS) treatment for auditory hallucinations and thinking problems in schizophrenia
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Scientific title
A randomized controlled trial of transcranial Direct Current Stimulation to reduce auditory hallucinations and enhance cognitive function in schizophrenia
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Secondary ID [1]
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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Condition category
Condition code
Mental Health
257251
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0
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Schizophrenia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
transcranial Direct Current Stimulation (tDCS)
TDCS involves the application of a mild constant electrical current of 2 mA to predefined brain regions of interest through placement of electrodes on the scalp surface. The current induces intracerebral current flow. This current flow then either increases or decreases the neuronal excitability in the specific area being stimulated based on which type of stimulation is being used: cathodal (decreases excitability), or anodal (increases excitability).
The total duration of a single session is 20 minutes. Each treatment phase will include 20 consecutive weekdays (or 4 weeks). Participants may continue for up to 12 weeks, depending on the allocation within the trial, and therapeutic responsiveness.
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Intervention code [1]
256262
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Treatment: Devices
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Comparator / control treatment
The study will involve 2 phases. In the first phase of this study all 40 participants will be randomly assigned to 4 weeks of either active asymmetrical tDCS or sham treatment using a double-blind design, such that half of the participants will receive active and half of the participants will receive sham treatment. During the second phase of the study all participants in the active arm will be assigned to another 4 weeks of either asymmetrical tDCS or bilateral tDCS on the basis of treatment response: those responding to asymmetrical will continue with asymmetrical tDCS, while those not responding to asymmetrical tDCS will begin bilateral tDCS – see below, using an “open label” un-blinded design. Following 4 weeks of sham treatment, participants in this arm will enter an arm of 4 weeks of active tDCS, randomized to either asymmetrical or bilateral tDCS.
The active and sham treatments will have a duration of 20 minutes and will be conducted on consecutive weekdays. In the case of the asymmetrical tDCS set-up, the location of the cathodal electrode will be the temporo-parietal junction (TPJ) of the left hemisphere, and the anodal electrode will be placed over the right dorsolateral prefrontal cortex (DLPFC). Stimulation will be conducted at 2mAmp intensity. In the case of bilateral tDCS, 4 sites wil be stimulated at 1 mAmp intensity: cathodal electrodes will be positioned over the bilateral TPJ and anodal electrodes will be positioned over the bilateral DLPFC.
Assessments of symptom severity, cognitive function, general daily functioning, as well as Brain Derived Neurotrophic Factor (BDNF) levels in the blood, and brain activity measured by means of Magnetic Resonance Imaging (MRI) will be conducted at baseline and following each 4 week treatment period of the study.
The first phase will use a double-blind design in which the tDCS administrator will be aware of the active or sham condition, but both the patient and the researchers administering the clinical and cognitive assessments will not be aware of the treatment condition.
Sham tDCS will consist of the same set-up and electrode positions as the actual tDCS treatment. However, the stimulator will be turned on for just 30 seconds, during which time current intensity will be ramped up, an back down. This will provide a similar sensation to the actual tDCS, decreasing the likelihood that participants will notice the difference between real and sham tDCS.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Severity of positive and negative symptoms in schizophrenia measured by means of the Positive and Negative Syndrome Scale (PANSS), Psychotic Symptoms Rating Scale (PSYRATS), and the Hallucinations Rating Scale (AHRS).
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Assessment method [1]
258154
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Timepoint [1]
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Baseline
After each 4 week treatment phase
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Secondary outcome [1]
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Magnetic resonance imaging (MRI) consisting of a a high resolution structural MRI scan, an MR spectroscopy scan using a MEGA-PRESS technique to measure concentrations of glutamate/glutamine and gamma-aminobutyric acid (GABA) in the frontal lobe, and a resting state functional MRI will provide data for connectivity analyses. These brain measures will be correlated with the primary clinical outcome measures.
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Assessment method [1]
263790
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Timepoint [1]
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Baseline
After each 4 week treatment phase
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Secondary outcome [2]
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Brain Derived Neurotrophic Factor (BDNF) genetic analysis and blood levels
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Assessment method [2]
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Timepoint [2]
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Baseline
After each 4 week treatment phase
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Secondary outcome [3]
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Cognitive function as measured by the MATRICS battery of cognitive tests (especially tests of working memory).
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Assessment method [3]
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Timepoint [3]
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Baseline and week 4
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Eligibility
Key inclusion criteria
Patients will be included if they (1) are competent to give informed consent, as determined by the referring physician or psychiatrist, (2) have persistent symptoms despite treatment with antipsychotic medication for at least 12 months, and (3) are between 18 and 50 years of age.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients will be excluded if (1) they are receiving carbamazepine since it may interfere with the effects of anodal tDCS, (2) have a history of substance abuse or dependence within the past year, (3) have a concomitant neurological disorder, or (4) they are pregnant. Patients will continue their regular medication regime for the duration of the tDCS treatment trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be attained by means of sequentially numbered opaque, sealed envelopes (SNOSE)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table created by a computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
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Other reasons
Recruitment difficulties and 5 year limitation of Ethics approval reached.
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Date of first participant enrolment
Anticipated
1/07/2010
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Actual
15/09/2010
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Date of last participant enrolment
Anticipated
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Actual
13/01/2015
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Date of last data collection
Anticipated
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Actual
11/03/2015
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Sample size
Target
40
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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National Alliance for Research on Schizophrenia and Depression (NARSAD)
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Address [2]
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60 Cutter Mill Road, Suite 404
Great Neck, New York 11021
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Country [2]
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United States of America
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Primary sponsor type
University
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Name
University of New South Wales
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Address
The University of New South Wales
SYDNEY
NSW 2052
AUSTRALIA
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
256044
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Country [1]
256044
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of New South Wales, Human Research Ethics Committee
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Ethics committee address [1]
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Ethics Secretariat
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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06/04/2010
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Approval date [1]
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07/06/2010
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Ethics approval number [1]
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UNSW HREC 10102
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Summary
Brief summary
The objective of this study is to assess to what extent cathodal transcranial Direct Current Stimulation (tDCS) of the temporal cortex, in conjunction with anodal tDCS of the prefrontal cortex, may reduce auditory hallucinations, and induce improvements in cognition, and negative symptoms in people with schizophrenia who are concurrently maintained on antipsychotic treatment. The central hypothesis is that cognitive deficits and negative symptoms, having been linked to prefrontal cortex dysfunction, will be reduced by anodal stimulation of the prefrontal cortex via facilitation of neural function, and that cathodal stimulation of the temporal cortex will reduce auditory hallucinations through disruption of pathological over-activity.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Thomas Weickert
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Address
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Neuroscience Research Australia (NeuRA)
138 Barker Street
Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 9399 1730
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Thomas Weickert
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Address
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Neuroscience Research Australia (NeuRa)
Hospital Road
Randwick, NSW, 2031
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Country
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Australia
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Phone
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+61 2 9399 1730
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Fax
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Query!
Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Dr. Thomas Weickert
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Address
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Neuroscience Research Australia (NeuRa)
Hospital Road
Randwick, NSW, 2031
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Country
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Australia
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Phone
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+61 2 9399 1730
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Fax
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+61 2 9399 1034
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23175
Study protocol
[email protected]
23176
Statistical analysis plan
[email protected]
23177
Clinical study report
[email protected]
23178
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4281
Study results article
Yes
Weickert TW, Salimuddin H, Lenroot RK, Bruggemann ...
[
More Details
]
335341-(Uploaded-19-11-2023-05-57-31)-Journal results publication.pdf
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Transcranial magnetic stimulation (TMS) for schizophrenia.
2015
https://dx.doi.org/10.1002/14651858.CD006081.pub2
Embase
Preliminary findings of four-week, task-based anodal prefrontal cortex transcranial direct current stimulation transferring to other cognitive improvements in schizophrenia.
2019
https://dx.doi.org/10.1016/j.psychres.2019.112487
N.B. These documents automatically identified may not have been verified by the study sponsor.
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