NCT01653431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

5.8 years

First QC Date

July 30, 2012

Last Update Submit

February 6, 2020

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • California Verbal Learning Test II

    Post treatment

Study Arms (2)

Transcranial direct current stimulation

EXPERIMENTAL

Transcranial direct current stimulation combined with cognitive training

Device: Transcranial direct current stimulation

Sham transcranial direct current stimulation

SHAM COMPARATOR

Sham transcranial direct current stimulation combined with cognitive training

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE
Sham transcranial direct current stimulationTranscranial direct current stimulation

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 - 85 years.
  • Meet diagnostic criteria for amnestic mild cognitive impairment.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Dog Institute

Sydney, New South Wales, 2031, Australia

Location

Related Publications (1)

  • 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.

    PMID: 31424410DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 30, 2012

First Posted

July 31, 2012

Study Start

January 1, 2013

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations

AU(1)