- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03249961
How Many Days Would You Want to Practice a Skill to Achieve it?
October 23, 2020 updated by: Sunnybrook Health Sciences Centre
Practice is required to improve your shot in basketball or to play a musical instrument.
The learning of these motor skills can be further enhanced by non-invasively stimulating regions of the brain that control movements with electrical currents.
These electric currents can strengthen or weaken connections of the brain, which consequently affects a person's ability to improve their performance on a skill.
Non-invasive brain stimulation (NIBS) is widely applied in many disciplines of neuroscience research, and has potential therapeutic application.
There are two specific types of NIBS that will be used in this research study: 1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the brain.
Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated, painless, and safe.
The application of tDCS to brain regions that control movements, concurrently with practice of a skill, results in better skill performance, than practice alone with no tDCS.
Therefore, in this study, we will be testing different types of brain stimulation and different amounts of practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
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
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Center
-
-
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 44 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- prior history of neurological or psychiatric disease
- prior experience with the motor task used
- contraindications to TMS and TDCS (e.g., metal implants, history of seizures and headaches)
- musculoskeletal injury to upper limb
- drugs that interact with NIBS (e.g., antidepressants, antipsychotics, anticonvulsants)
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Placebo Brain stimulation
Participants will receive Sham TDCS, and Transcranial Magnetic Stimulation (TMS)
|
Placebo stimulation is applied to the left motor cortex while participants perform a motor task in the right hand.
During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.
Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex.
|
Experimental: Excitatory Brain Stimulation
Participants will receive Anodal TDCS, and Transcranial Magnetic Stimulation (TMS)
|
Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex.
Excitatory stimulation is applied to the left motor cortex while participants perform a motor task in the right hand.
During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy
Time Frame: Up to 8 days
|
Accuracy is defined as the proportion of trials per block with hits to all targets in the correct sequence order.
|
Up to 8 days
|
Speed
Time Frame: Up to 8 days
|
Speed is captured by the average sequence movement time per training block
|
Up to 8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joyce Chen, PhD, Sunnybrook Research Institute
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 (Actual)
April 20, 2018
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
August 31, 2020
Study Registration Dates
First Submitted
August 2, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (Actual)
August 15, 2017
Study Record Updates
Last Update Posted (Actual)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 23, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 175-2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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