Clinical trial NCT01135953: Methods to Enhance Transcranial Direct Stimulation (tDCS)
Official title: Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Brain Excitation
Keywords: Brain excitation
transcranial Direct Stimulation
administration pattern
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in brain excitability measured through motor evoked potentials (MEP) 0 to 120 minutes after tDCS session.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Black Dog Institute, University of New South Wales
state: New South Wales
Study officials:
References: