Executive FunctionNCT02498574

Performance Enhancement and Non-Invasive Brain Stimulation

A study testing Transcranial Direct Current Stimulation and Working Memory Training in people with Executive Function and Motor Activity, run by Bruyère Health Research Institute. at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Executive Function, Motor Activity, Brain Stimulation
What is being tested?: Transcranial Direct Current Stimulation and Working Memory Training
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 2 sitesCanada
Study dates: Aug 2016to Aug 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Bruyere Continuing Care
Ottawa, Ontario, K1N 5C8
Bruyere Research Institute
Ottawa, Ontario

Other trials in Canada

About this study

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.

Read the detailed description

This study involves a single session of anodal tDCS, applied over the motor cortex, while performing a task of motor dexterity. Pre and post stimulation evaluations will assess any effects of the stimulation on motor and cognitive performance.

Conditions: Executive Function, Motor Activity, Brain Stimulation
Being tested: Transcranial Direct Current Stimulation, Working Memory Training
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Direct Current StimulationDevice
Non-invasive brain stimulation applied to the surface of the scalp
Working Memory TrainingBehavioural
Cognitively challenging game played concurrently with transcranial direct-current stimulation

Study groups in NCT02498574
Study group	Role	What they receive
Group 1	Experimental	Non-invasive brain stimulation protocol expected to improve performance, with cognitively challenging game Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Working Memory Training
Group 2	Placebo comparator	Non-invasive brain stimulation protocol not expected to improve performance, with cognitively challenging game Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Working Memory Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Post-test following 20-minute stimulation period
Change in cognitive performance
We will measure changes in cognitive performance on neuropsychological tests.
Measured: 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.
Measured: Baseline, Post-test following 20-minute stimulation period
Change in motor performance
We will measure changes in motor performance on the Grooved Pegboard task.
Measured: Baseline, Post-test following 20-minute stimulation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Aug 2018

First posted15 Jul 2015 (estimated)
Study startAug 2016
Primary completionAug 2017
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Executive FunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02498574
Sponsor's protocol ID: M16-15-015
Status last verified: Jul 2019
First submitted: 9 Jul 2015
Last updated: 2 Aug 2019
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Acute Effects of Cannabis on Cognition and Affect
Cannabis Use
Recruiting
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
TBI, Cognitive Dysfunction
Enrolling by invitation
Effects of a School-Based Physical Activity Intervention on 24-Hour Movement Behaviours and Motor Development in Preschool Children - Study Protocol
Physical Inactivity, Sedentariness
Recruiting
Sleep Coach for Adolescents With Type 1 Diabetes
Type 1 Diabetes
Recruiting
Improving Academic and Social Functioning in Middle-Schoolers With Autism
Autism, Autism Spectrum Disorder

All Executive Function trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Enhancement and Non-Invasive Brain Stimulation
ClinicalTrials.gov ID: NCT02498574
Acronym / sponsor ID: M16-15-015
Conditions: Executive Function, Motor Activity, Brain Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Bruyère Health Research Institute.University, hospital or other
Study start: Aug 2016
Primary completion: Aug 2017 (actual)
Study completion: Aug 2018 (actual)
First posted: 15 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Device: Transcranial Direct Current Stimulation, Behavioral: Working Memory TrainingNon-invasive brain stimulation protocol expected to improve performance, with cognitively challenging game
Group 2	Placebo comparator	Device: Transcranial Direct Current Stimulation, Behavioral: Working Memory TrainingNon-invasive brain stimulation protocol not expected to improve performance, with cognitively challenging game

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Direct Current StimulationNon-invasive brain stimulation applied to the surface of the scalp	Device	Group 1, Group 2
Working Memory TrainingCognitively challenging game played concurrently with transcranial direct-current stimulation	Behavioural	Group 1, Group 2

Primary outcome

Change in ratings on cognitive training survey
Time frame: Baseline, Post-test following 20-minute stimulation period
This survey aims to assess participant perceptions on brain stimulation, and includes a series of related questions, rated on a scale of 1-7.
Change in cognitive performance
Time frame: Baseline, Post-test following 20-minute stimulation period
We will measure changes in cognitive performance on neuropsychological tests.
Change in game performance
Time frame: Baseline, Post-test following 20-minute stimulation period
We will measure changes in performance on a cognitively-challenging game performed concurrently with the non-invasive brain stimulation.
Change in motor performance
Time frame: Baseline, Post-test following 20-minute stimulation period
We will measure changes in motor performance on the Grooved Pegboard task.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
Dr. Patrick DavisonLink provided by the sponsor.

Related trials for Executive Function

RecruitingPhase 1
Acute Effects of Cannabis on Cognition and Affect
Cannabis Use
Recruiting
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
TBI, Cognitive Dysfunction
Enrolling by invitation
Effects of a School-Based Physical Activity Intervention on 24-Hour Movement Behaviours and Motor Development in Preschool Children - Study Protocol
Physical Inactivity, Sedentariness
Recruiting
Sleep Coach for Adolescents With Type 1 Diabetes
Type 1 Diabetes
Recruiting
Improving Academic and Social Functioning in Middle-Schoolers With Autism
Autism, Autism Spectrum Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sheida Rabipour, PhD principal investigator

University of Ottawa

Francois Tremblay, PT, PhD principal investigator

Bruyere Continuing Care

Patrick SR Davidson, PhD principal investigator

University of Ottawa

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ratings on cognitive training survey (time frame: Baseline, Post-test following 20-minute stimulation period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02498574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.