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Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Completed
CT.gov ID
NCT02060708
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
5
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HD-tDCS
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Measuring the Stimulated Brain: Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: Real HD-tDCS first, Sham HD-tDCS second

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)

Device: HD-tDCS
HD-tDCS non-invasive brain stimulation using this same device (Soterix) has been designated a 'non-significant risk' by the US FDA.
Other Names:
  • High Definition Transcranial Direct Current Stimulation

    		•
    Other: Sham HD-tDCS first, Real HD-tDCS second

    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)

    Device: HD-tDCS
    HD-tDCS non-invasive brain stimulation using this same device (Soterix) has been designated a 'non-significant risk' by the US FDA.
    Other Names:
  • High Definition Transcranial Direct Current Stimulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in brain activity [Immediate (20 minutes)]

      Assessment of changes in brain activity will be done using both event-related and frequency domain beam former localization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Normal hearing and vision
    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Hospital for Sick Children Toronto Ontario Canada M5J0A6

    Sponsors and Collaborators

    • The Hospital for Sick Children

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas Cheyne, Senior Scientist and Associate Professor, Diagnostic Imaging, The Hospital for Sick Children
    ClinicalTrials.gov Identifier:
    NCT02060708
    Other Study ID Numbers:
    • 1000042023
    First Posted:
    Feb 12, 2014
    Last Update Posted:
    Apr 21, 2016
    Last Verified:
    Apr 1, 2016

    Study Results

    No Results Posted as of Apr 21, 2016