NCT02498574

Brief Summary

A promising form of enhancing brain function non-invasively involves stimulating the brain using weak magnetic or electric currents. This method is becoming increasingly popular in both clinical and commercial circles; a number of portable, at-home devices are available on the commercial market for personal use. In this study, the investigators aim to determine factors associated with the enhancement of cognitive and motor learning following transcranial direct-current stimulation in healthy young adults. Understanding how participants respond to brain stimulation is critical to maximizing the effectiveness of stimulation and determining its potential as a performance-enhancing aid for mental tasks. Future developments of this study may also inform the capacity of brain stimulation to act as non-drug alternative to treatment for cognitive decline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 9, 2015

Last Update Submit

July 31, 2019

Conditions

Executive FunctionMotor ActivityBrain Stimulation

Outcome Measures

Primary Outcomes (4)

  • Change in ratings on cognitive training survey

    This survey aims to assess participant perceptions on brain stimulation, and includes a series of related questions, rated on a scale of 1-7.

    Baseline, Post-test following 20-minute stimulation period

  • Change in cognitive performance

    We will measure changes in cognitive performance on neuropsychological tests.

    Baseline, Post-test following 20-minute stimulation period

  • Change in game performance

    We will measure changes in performance on a cognitively-challenging game performed concurrently with the non-invasive brain stimulation.

    Baseline, Post-test following 20-minute stimulation period

  • Change in motor performance

    We will measure changes in motor performance on the Grooved Pegboard task.

    Baseline, Post-test following 20-minute stimulation period

Study Arms (2)

Group 1

EXPERIMENTAL

Non-invasive brain stimulation protocol expected to improve performance, with cognitively challenging game

Device: Transcranial Direct Current StimulationBehavioral: Working Memory Training

Group 2

PLACEBO COMPARATOR

Non-invasive brain stimulation protocol not expected to improve performance, with cognitively challenging game

Device: Transcranial Direct Current StimulationBehavioral: Working Memory Training

Interventions

Transcranial Direct Current StimulationDEVICE

Non-invasive brain stimulation applied to the surface of the scalp

Group 1Group 2
Working Memory TrainingBEHAVIORAL

Cognitively challenging game played concurrently with transcranial direct-current stimulation

Group 1Group 2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must be in good health,
  • between 18-35 years of age
  • with no prior history of neurological diseases such as multiple sclerosis, Parkinson's disease, stroke with paralysis.

You may not qualify if:

  • Participants with cardiac stimulators (pace-makers) and those with metal implants in the skull will be excluded.
  • Pregnant women will also be excluded.
  • Participants will be required to fill out a brief health questionnaire to ensure that they have no conditions that would prevent brain stimulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bruyere Continuing Care

Ottawa, Ontario, K1N 5C8, Canada

Location

Bruyere Research Institute

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Sheida Rabipour, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

  • Francois Tremblay, PT, PhD

    Bruyere Continuing Care

    PRINCIPAL INVESTIGATOR

  • Patrick SR Davidson, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 15, 2015

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2018

Last Updated

August 2, 2019

Record last verified: 2019-07

Locations

CA(2)