Motor LearningNCT03249961
How Many Days Would You Want to Practice a Skill to Achieve it?
A study testing Anodal TDCS and Transcranial Magnetic Stimulation (TMS) in people with Motor Learning, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Learning
- What is being tested?
- Anodal TDCS and Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2018to 31 Aug 2020
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Motor Learning
- Being tested
- Sham TDCS, Anodal TDCS, Transcranial Magnetic Stimulation (TMS)
- Keywords
- motor, transcranial direct current stimulation, transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TDCSDevice
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.
Anodal TDCSDevice
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.
Transcranial Magnetic Stimulation (TMS)Device
Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Brain stimulation | Experimental | Participants will receive Sham TDCS, and Transcranial Magnetic Stimulation (TMS) Receives: Device: Sham TDCS; Device: Transcranial Magnetic Stimulation (TMS) |
| Excitatory Brain Stimulation | Experimental | Participants will receive Anodal TDCS, and Transcranial Magnetic Stimulation (TMS) Receives: Device: Anodal TDCS; Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy is defined as the proportion of trials per block with hits to all targets in the correct sequence order.
Measured: Up to 8 days
Speed
Speed is captured by the average sequence movement time per training block
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start20 Apr 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor LearningStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyce Chen, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249961
- Sponsor's protocol ID
- 175-2017
- Status last verified
- Oct 2020
- First submitted
- 2 Aug 2017
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Many Days Would You Want to Practice a Skill to Achieve it?
- ClinicalTrials.gov ID
- NCT03249961
- Acronym / sponsor ID
- 175-2017
- Conditions
- Motor Learning
- Keywords
- motor, transcranial direct current stimulation, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 15 Aug 2017 (actual)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Brain stimulation | Experimental | Device: Sham TDCS, Device: Transcranial Magnetic Stimulation (TMS)Participants will receive Sham TDCS, and Transcranial Magnetic Stimulation (TMS) |
| Excitatory Brain Stimulation | Experimental | Device: Anodal TDCS, Device: Transcranial Magnetic Stimulation (TMS)Participants will receive Anodal TDCS, and Transcranial Magnetic Stimulation (TMS) |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Sham TDCSPlacebo 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. | Device | Placebo Brain stimulation |
| Anodal TDCSExcitatory 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. | Device | Excitatory Brain Stimulation |
| Transcranial Magnetic Stimulation (TMS)Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex. | Device | Excitatory Brain Stimulation, Placebo Brain stimulation |
Primary outcome
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.
Speed
Time frame: Up to 8 days
Speed is captured by the average sequence movement time per training block
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 27 Oct 2020.
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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.
Joyce Chen, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal TDCS and Transcranial Magnetic Stimulation (TMS) in people with Motor Learning, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 inclusion and 5 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Accuracy (time frame: Up to 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2020.