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

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ClinicalTrials.gov Identifier: NCT02060708
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Douglas Cheyne, The Hospital for Sick Children

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
Real HD-tDCS Sham HD-tDCS Visual Task Motor Task Auditory Task Working Memory Task Device: HD-tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
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 Name: High Definition Transcranial Direct Current Stimulation

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 Name: High Definition Transcranial Direct Current Stimulation




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060708


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5J0A6
Sponsors and Collaborators
The Hospital for Sick Children

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Responsible Party: Douglas Cheyne, Senior Scientist and Associate Professor, Diagnostic Imaging, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02060708     History of Changes
Other Study ID Numbers: 1000042023
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016