Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
Measuring the Stimulated Brain: Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
1 other identifier
interventional
16
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2014
CompletedFirst Posted
Study publicly available on registry
February 12, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedApril 21, 2016
April 1, 2016
5 months
February 6, 2014
April 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Immediate (20 minutes)
Study Arms (2)
Real HD-tDCS first, Sham HD-tDCS second
OTHERReal 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
OTHERSham 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)
Interventions
HD-tDCS non-invasive brain stimulation using this same device (Soterix) has been designated a 'non-significant risk' by the US FDA.
Eligibility Criteria
You may qualify if:
- Normal hearing and vision
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5J0A6, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist and Associate Professor, Diagnostic Imaging
Study Record Dates
First Submitted
February 6, 2014
First Posted
February 12, 2014
Study Start
January 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
April 21, 2016
Record last verified: 2016-04