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

Auditory Task Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060708
• Other study ID #: 1000042023
• Status: Completed
• Phase: N/A
• First received: February 6, 2014
• Last updated: April 19, 2016
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Auditory Task
• Motor Task
• Real HD-tDCS
• Sham HD-tDCS
• Visual Task
• Working Memory Task

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No