Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000217808
Ethics application status
Approved
Date submitted
6/02/2012
Date registered
21/02/2012
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can Transcranial Electrical Stimulation enhance working memory in schizophrenia and healthy controls?
Scientific title
Non-invasive brain stimulation and working memory enhancement in schizophrenia and healthy controls: investigating transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS).
Secondary ID [1] 279868 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia / Schizoaffective disorder 285657 0
Condition category
Condition code
Mental Health 285835 285835 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anodal transcranial direct current stimulation (tDCS) at 2mA intensity, and anodal transcranial Alternating Current Stimulation (tACS) at 1mA intensity with gamma frequency range of 30-40Hz. This will be applied to the left dorsolateral prefrontal cortex for 20 minutes using a neuroConn GBH/Eldith DC Stimulator. tDCS will be delivered during three sessions (one tDCS, one tACS, and one sham tDCS) that will be one week apart.
Intervention code [1] 284099 0
Treatment: Devices
Comparator / control treatment
Sham transcranial direct current stimulation (tDCS). This will involve placing the electrodes in the same position as for active tDCS, however stimulation will be ceased after 30 seconds (so as to generate the same initial sensation and ensure blinding is maintained).
Control group
Placebo

Outcomes
Primary outcome [1] 286343 0
A statistically significant improvement in performance on a working memory task (i.e. N-Back) following application of tDCS/tACS stimulation, both in patients with schizophrenia/ schizoaffective disorder and in healthy controls.
Timepoint [1] 286343 0
Before and after application of tDCS/tACS stimulation
Primary outcome [2] 286344 0
A statistically significant improvement in performance on the N-Back working memory task following application of anodal tDCS or tACS stimulation, compared with sham stimulation, both in patients with schizophrenia/ schizoaffective disorder and in healthy controls.
Timepoint [2] 286344 0
Comparison of conditions - Session 1 vs Session 2 vs Session 3.

Participants' performance on the N-Back task will be measured for each session, both during and immediately after tDCS/tACS/sham stimulation. At the end of the trial, a final analysis will be conducted to compare participants' performance on the N-back across the three stimulation conditions.
Secondary outcome [1] 295891 0
Nil
Timepoint [1] 295891 0
Nil

Eligibility
Key inclusion criteria
Participants with schizophrenia will be included if they:
- are voluntary and competent to consent
- have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV)

Healthy individuals will be included if they:
- have capacity to consent
- have no personal history of psychiatric illness (lifetime) - based on self report.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with schizophrenia will be excluded if they:
- have a a DSM-IV history of substance abuse or dependence in the last 6 months
- have a concomitant major and/or unstable medical or neurologic illness
- are currently taking carbamazepine
- are currently pregnant or lactating
- have metal anywhere in the head, except the mouth (this includes metallic objects such as screws and clips from surgical procedures)

Healthy participants will be excluded if they:
- have an unstable medical condition, neurological disorder or are currently pregnant or lactating
- have metal in the cranium, a pacemaker, cochlear implant medication pump or other electronic device

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a double-blind study. Neither the participant nor the researcher conducting the sessions will know what type of stimulation the participant is receiving during each session. The Chief Investigator, who will be unblinded, will provide a unique code to be entered into the tDCS stimulator, which will determine the stimulation condition and settings, thus allowing the second researcher to remain blinded. The stimulation condition will be counterbalanced across participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/02/2012
Actual
2/02/2012
Date of last participant enrolment
Anticipated
Actual
17/07/2014
Date of last data collection
Anticipated
Actual
31/07/2014
Sample size
Target
40
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284628 0
University
Name [1] 284628 0
Accelerator Program Funding, Monash University
Country [1] 284628 0
Australia
Primary sponsor type
Individual
Name
Dr. Kate Hoy
Address
MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 283552 0
None
Name [1] 283552 0
Address [1] 283552 0
Country [1] 283552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286618 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 286618 0
Ethics committee country [1] 286618 0
Australia
Date submitted for ethics approval [1] 286618 0
Approval date [1] 286618 0
07/12/2011
Ethics approval number [1] 286618 0
1/11/0416

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33667 0
A/Prof Kate Hoy
Address 33667 0
MAPrc, Level 4 607 St Kilda Road
Melbourne, VIC 3004
Country 33667 0
Australia
Phone 33667 0
+61 3 90765034
Fax 33667 0
Email 33667 0
kate.hoy@monash.edu
Contact person for public queries
Name 16914 0
Ms. Sara Arnold
Address 16914 0
MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
Country 16914 0
Australia
Phone 16914 0
+61 3 9076 6592
Fax 16914 0
Email 16914 0
sara.arnold@monash.edu
Contact person for scientific queries
Name 7842 0
Dr. Kate Hoy
Address 7842 0
MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
Country 7842 0
Australia
Phone 7842 0
+61 3 9076 5034
Fax 7842 0
Email 7842 0
k.hoy@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.