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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Secondary ID [1] 0 0
HC12381
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
California Verbal Learning Test II
Timepoint [1] 0 0
Post treatment

Eligibility
Key inclusion criteria
* Aged 60 - 85 years.
* Meet diagnostic criteria for amnestic mild cognitive impairment.
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01653431