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Methods to Enhance Transcranial Direct Stimulation (tDCS)

This study has been completed.
Sponsor:
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01135953
First received: June 2, 2010
Last updated: December 7, 2010
Last verified: December 2010

June 2, 2010
December 7, 2010
January 2010
July 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Brain excitability measured through motor evoked potentials (MEP) [ 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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01135953 on ClinicalTrials.gov Archive Site
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Methods to Enhance Transcranial Direct Stimulation (tDCS)
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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
  • Healthy Volunteers
  • Brain Excitation
  • Device: Transcranial Direct Current Stimulation (tDCS)
    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 Name: tDCS (Eldith DC-Stimulator (CE certified)
  • Device: Transcranial Direct Current Stimulation (tDCS)
    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 Name: Eldith DC-Stimulator (CE certified)
  • Other: Transcranial direct Stimulation (tDCS) and D-cycloserine

    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:
    • tDCS - Eldith DC-Stimulator (CE certified)
    • D-cycloserine, Seromycin Pulvules, 100 mg
  • Experimental: ARM 1 - CONTROL
    Subject given tDCS every day of the week (5 sessions) at 2 mA.
    Intervention: Device: Transcranial Direct Current Stimulation (tDCS)
  • 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).
    Intervention: Device: Transcranial Direct Current Stimulation (tDCS)
  • Experimental: ARM 3 - CYCLOSERINE
    D-cycloserine (100 mg) given on the Monday and Thursday sessions, administering tDCS at 2 mA.
    Intervention: Other: Transcranial direct Stimulation (tDCS) and D-cycloserine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01135953
HREC09344
Yes
Associate Professor Colleen Loo, School of Psychiatry, University of New South Wales
The University of New South Wales
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The University of New South Wales
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP