Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by The University of New South Wales
Sponsor:
Information provided by (Responsible Party):
Melissa Pigot, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01653431
First received: July 30, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Device: Transcranial direct current stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • California Verbal Learning Test II [ Time Frame: Post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial direct current stimulation
Transcranial direct current stimulation combined with cognitive training
Device: Transcranial direct current stimulation
Sham Comparator: Sham transcranial direct current stimulation
Sham transcranial direct current stimulation combined with cognitive training
Device: Transcranial direct current stimulation

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653431

Contacts
Contact: Donel M Martin, PhD 61 2 9382 9261 donel.martin@unsw.edu.au

Locations
Australia, New South Wales
Black Dog Institute Recruiting
Sydney, New South Wales, Australia, 2031
Sub-Investigator: Donel M Martin, PhD         
Sponsors and Collaborators
The University of New South Wales
  More Information

No publications provided

Responsible Party: Melissa Pigot, Research Assistant, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01653431     History of Changes
Other Study ID Numbers: HC12381
Study First Received: July 30, 2012
Last Updated: August 11, 2014
Health Authority: Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Mild Cognitive Impairment
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014