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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01653431
Registration number
NCT01653431
Ethics application status
Date submitted
30/07/2012
Date registered
31/07/2012
Date last updated
7/02/2020
Titles & IDs
Public title
Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment
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Scientific title
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Secondary ID [1]
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HC12381
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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:
Mild Cognitive Impairment
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Transcranial direct current stimulation
Experimental: Transcranial direct current stimulation - Transcranial direct current stimulation combined with cognitive training
Sham Comparator: Sham transcranial direct current stimulation - Sham transcranial direct current stimulation combined with cognitive training
Treatment: Devices: Transcranial direct current stimulation
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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California Verbal Learning Test II
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Assessment method [1]
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Timepoint [1]
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Post treatment
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Eligibility
Key inclusion criteria
- Aged 60 - 85 years.
- Meet diagnostic criteria for amnestic mild cognitive impairment.
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Minimum age
60
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Inability to provide informed consent.
- Concurrent medication likely to affect mental performance.
- Current substance use or dependence in last 3 months.
- Current active psychiatric or neurological condition
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2019
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Sample size
Target
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Accrual to date
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Final
68
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Black Dog Institute - Sydney
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Recruitment postcode(s) [1]
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2031 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of New South Wales
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study will examine whether the effects of computerized brain training are enhanced when
training is combined with mild brain stimulation in patients with mild cognitive impairment.
We hypothesize that this combination will produce greater improvements in cognitive
functioning than computerized brain training alone.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01653431
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01653431
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