- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498574
Performance Enhancement and Non-Invasive Brain Stimulation
July 31, 2019 updated by: Bruyere Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
121
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada
- Bruyere Research Institute
-
Ottawa, Ontario, Canada, K1N 5C8
- Bruyère Continuing Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Non-invasive brain stimulation protocol expected to improve performance, with cognitively challenging game
|
Non-invasive brain stimulation applied to the surface of the scalp
Cognitively challenging game played concurrently with transcranial direct-current stimulation
|
|
Placebo Comparator: Group 2
Non-invasive brain stimulation protocol not expected to improve performance, with cognitively challenging game
|
Non-invasive brain stimulation applied to the surface of the scalp
Cognitively challenging game played concurrently with transcranial direct-current stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, Post-test following 20-minute stimulation period
|
|
Change in cognitive performance
Time Frame: Baseline, Post-test following 20-minute stimulation period
|
We will measure changes in cognitive performance on neuropsychological tests.
|
Baseline, Post-test following 20-minute stimulation period
|
|
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.
|
Baseline, Post-test following 20-minute stimulation period
|
|
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.
|
Baseline, Post-test following 20-minute stimulation period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sheida Rabipour, PhD, University of Ottawa
- Principal Investigator: Francois Tremblay, PT, PhD, Bruyère Continuing Care
- Principal Investigator: Patrick SR Davidson, PhD, University of Ottawa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
July 9, 2015
First Submitted That Met QC Criteria
July 13, 2015
First Posted (Estimate)
July 15, 2015
Study Record Updates
Last Update Posted (Actual)
August 2, 2019
Last Update Submitted That Met QC Criteria
July 31, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- M16-15-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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