Methods to Enhance Transcranial Direct Stimulation (tDCS)
December 7, 2010 updated by: The University of New South Wales
Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS)
tDCS has been shown to be an effective treatment for depression.
However, tDCS is a relatively new clinical tool and more needs to be understood about its use.
This study hopes to further the field of knowledge by examining how tDCS should be optimally used.
Application of tDCS in clinical trials of depression is typically to the prefrontal cortex, but in this project, tDCS application will be to the motor cortex as it provides a more ready measure of excitability.
Excitability will be measured using Transcranial Magnetic Stimulation (TMS) to the motor cortex and electromyography (EMG) recordings from peripheral muscles stimulated.
Using a cross-over three-arm design this study aims to investigate whether daily tDCS administered in increasing intensity across sessions leads to greater and lasting effects on brain excitability than keeping the intensity at a same dose across the days and whether the excitatory effect could be enhanced with D-cycloserine, a medication known to prolong the excitatory effects of a single session of tDCS.
This in turn will inform on how to optimize tDCS for therapeutic applications, e.g treatment of depression.
The study hypothesis is that 5 sessions of tDCS with a dose of D-cycloserine given on the Monday and Thursday sessions will result in more sustained effect on motor cortex excitability than 5 sessions of tDCS alone.
The second hypothesis is that the gradational increases in tDCS intensity over 5 sessions will result in greater motor cortex excitability than 5 sessions of tDCS where intensity is kept constant across sessions.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2031
- Black Dog Institute, University of New South Wales
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Right handed (> 18/20 on the Edinburgh Handedness)
- Aged 18-40
Exclusion Criteria:
- Mental illness
- General medical illness
- Neurological illness, epilepsy
- Alcohol use above National Health and Medical Research Council (NHMRC) guidelines
- Smokers
- Excessive caffeine intake
- Illicit drug use
- Herbal medication use
- Electronic implant, e.g, cochlear implant, pacemaker
- Musculoskeletal problem in the arm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ARM 1 - CONTROL
Subject given tDCS every day of the week (5 sessions) at 2 mA.
|
tDCS applied to to motor cortex every weekday (5 sessions), at 2mA ,during 20 minutes.Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band.
The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
Other Names:
tDCS applied to the motor cortex every day of the week during 20 minutes, at 1mA first session, 1.5 mA second and third sessions, and 2mA fourth and fifth sessions, during 20 minutes.
Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band.
The current will be gradually increased over 30 seconds (to avoid the sensation of a flash).
Other Names:
|
|
Experimental: Arm 2 - INCREASING
Subjects given increasing intensity during tDCS across the week (Monday 1mA, Tuesday 1.5mA, Wednesday 1.5 mA, Thursday 2 mA, Friday 2mA).
|
tDCS applied to to motor cortex every weekday (5 sessions), at 2mA ,during 20 minutes.Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band.
The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
Other Names:
tDCS applied to the motor cortex every day of the week during 20 minutes, at 1mA first session, 1.5 mA second and third sessions, and 2mA fourth and fifth sessions, during 20 minutes.
Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band.
The current will be gradually increased over 30 seconds (to avoid the sensation of a flash).
Other Names:
|
|
Experimental: ARM 3 - CYCLOSERINE
D-cycloserine (100 mg) given on the Monday and Thursday sessions, administering tDCS at 2 mA.
|
Transcranial Direct Stimulation applied to the motor cortex every day of the week (5 sessions) at 2mA, during 20 minutes. Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash). D-cycloserine, administered orally (capsules), 100 mg, twice a week (Monday and Thursday), prior to the tDCS session.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in brain excitability measured through motor evoked potentials (MEP) 0 to 120 minutes after tDCS session.
Time Frame: Pre-treatment, post treatment at minute 0, minute 5, minute 10, minute 15, minute 20, minute 25, minute 30, minute 60, minute 90, minute 120.
|
Pre-treatment, post treatment at minute 0, minute 5, minute 10, minute 15, minute 20, minute 25, minute 30, minute 60, minute 90, minute 120.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
June 2, 2010
First Submitted That Met QC Criteria
June 2, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Estimate)
December 8, 2010
Last Update Submitted That Met QC Criteria
December 7, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREC09344
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