Back to resultsTranscranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- Aged 60 - 85 years.
- Meet diagnostic criteria for amnestic mild cognitive impairment.
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
Sites / Locations
- Black Dog Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Transcranial direct current stimulation
Sham transcranial direct current stimulation
Arm Description
Transcranial direct current stimulation combined with cognitive training
Sham transcranial direct current stimulation combined with cognitive training
Outcomes
Primary Outcome Measures
California Verbal Learning Test II
Secondary Outcome Measures
Full Information
NCT ID
NCT01653431
First Posted
July 30, 2012
Last Updated
February 6, 2020
Sponsor
The University of New South Wales
1. Study Identification
Unique Protocol Identification Number
NCT01653431
Brief Title
Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation combined with cognitive training
Arm Title
Sham transcranial direct current stimulation
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation combined with cognitive training
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Primary Outcome Measure Information:
Title
California Verbal Learning Test II
Time Frame
Post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 60 - 85 years.
Meet diagnostic criteria for amnestic mild cognitive impairment.
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
Facility Information:
Facility Name
Black Dog Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
31424410
Citation
Martin DM, Mohan A, Alonzo A, Gates N, Gbadeyan O, Meinzer M, Sachdev P, Brodaty H, Loo C. A Pilot Double-Blind Randomized Controlled Trial of Cognitive Training Combined with Transcranial Direct Current Stimulation for Amnestic Mild Cognitive Impairment. J Alzheimers Dis. 2019 Aug 12;71(2):503-512. doi: 10.3233/JAD-190306.
Results Reference
derived
Learn more about this trial
Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment
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