Real HD-tDCSNCT02060708
Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
A study testing HD-tDCS in people with Real HD-tDCS and Sham HD-tDCS, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Non-invasive human brain stimulation using weak transcranial direct-current stimulation (tDCS) has been thousands of times in research studies over the past fifteen years as a therapy to help improve the effectiveness of repeated training sessions (e.g., hand exercises in the context of daily physiotherapy), due to… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Real HD-tDCS, Sham HD-tDCS, Visual Task
- What is being tested?
- HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Jun 2015
- 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
- Normal hearing and vision
Who cannot join
- Current pregnancy
- Presence of metallic implants in the head
- Use of any medications
- Any history of mental health or neurological conditions
- Inability to perform any of the tasks for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Stimulated Brain: Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
Non-invasive human brain stimulation using weak transcranial direct-current stimulation (tDCS) has been thousands of times in research studies over the past fifteen years as a therapy to help improve the effectiveness of repeated training sessions (e.g., hand exercises in the context of daily physiotherapy), due to its safety, tolerability, convenience and cost-effectiveness. tDCS works by temporarily enhancing brain activity during performance of a specific task, helping with learning and training.
The investigators will use magnetoencephalography (MEG) brain imaging to view the real-time effects of high definition (HD) tDCS on several brain areas involved in vision, hearing, movement, and memory. The investigators hypothesize that changing the task (auditory, visual or memory task) but keeping the position of the electrodes over the motor cortex will result in modulation of brain activity in only the central target motor area, and not on non-target temporal, occipital or pre-frontal areas.
- Conditions
- Real HD-tDCS, Sham HD-tDCS, Visual Task, Motor Task, Auditory Task, Working Memory Task
- Being tested
- HD-tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCSDevice
Also called High Definition Transcranial Direct Current Stimulation
HD-tDCS non-invasive brain stimulation using this same device (Soterix) has been designated a 'non-significant risk' by the US FDA.
| Study group | Role | What they receive |
|---|---|---|
| Real HD-tDCS first, Sham HD-tDCS second | Other | Real HD-tDCS will be applied in the first session Sham HD-tDCS will be applied in the second session (at least one week after the first session) Receives: Device: HD-tDCS |
| Sham HD-tDCS first, Real HD-tDCS second | Other | Sham HD-tDCS will be applied in the first session Real HD-tDCS will be applied in the second session (at least one week after the first session) Receives: Device: HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in brain activity
Assessment of changes in brain activity will be done using both event-related and frequency domain beam former localization.
Measured: Immediate (20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Real HD-tDCSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Cheyne, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060708
- Sponsor's protocol ID
- 1000042023
- Status last verified
- Apr 2016
- First submitted
- 6 Feb 2014
- Last updated
- 21 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Stimulated Brain: Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
- ClinicalTrials.gov ID
- NCT02060708
- Acronym / sponsor ID
- 1000042023
- Conditions
- Real HD-tDCS, Sham HD-tDCS, Visual Task, Motor Task, Auditory Task, Working Memory Task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Feb 2014 (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.
Non-invasive human brain stimulation using weak transcranial direct-current stimulation (tDCS) has been thousands of times in research studies over the past fifteen years as a therapy to help improve the effectiveness of repeated training sessions (e.g., hand exercises in the context of daily physiotherapy), due to its safety, tolerability, convenience and cost-effectiveness. tDCS works by temporarily enhancing brain activity during performance of a specific task, helping with learning and training.
The investigators will use magnetoencephalography (MEG) brain imaging to view the real-time effects of high definition (HD) tDCS on several brain areas involved in vision, hearing, movement, and memory. The investigators hypothesize that changing the task (auditory, visual or memory task) but keeping the position of the electrodes over the motor cortex will result in modulation of brain activity in only the central target motor area, and not on non-target temporal, occipital or pre-frontal areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real HD-tDCS first, Sham HD-tDCS second | Other | Device: HD-tDCSReal HD-tDCS will be applied in the first session Sham HD-tDCS will be applied in the second session (at least one week after the first session) |
| Sham HD-tDCS first, Real HD-tDCS second | Other | Device: HD-tDCSSham HD-tDCS will be applied in the first session Real HD-tDCS will be applied in the second session (at least one week after the first session) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal hearing and vision
Key exclusion criteria (5 listed)
- Current pregnancy
- Presence of metallic implants in the head
- Use of any medications
- Any history of mental health or neurological conditions
- Inability to perform any of the tasks for any reason
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 |
|---|---|---|
| HD-tDCSAlso: High Definition Transcranial Direct Current StimulationHD-tDCS non-invasive brain stimulation using this same device (Soterix) has been designated a 'non-significant risk' by the US FDA. | Device | Real HD-tDCS first, Sham HD-tDCS second, Sham HD-tDCS first, Real HD-tDCS second |
Primary outcome
Change from baseline in brain activity
Time frame: Immediate (20 minutes)
Assessment of changes in brain activity will be done using both event-related and frequency domain beam former localization.
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 21 Apr 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tDCS in people with Real HD-tDCS and Sham HD-tDCS, run by The Hospital for Sick Children 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 21 Apr 2016. 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?
Change from baseline in brain activity (time frame: Immediate (20 minutes)). 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 21 Apr 2016.