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Completed

NCT Number: NCT01135953

Methods to Enhance 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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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Black Dog Institute, University of New South Wales

Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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 (Eldith DC-Stimulator (CE certified)

Transcranial direct Stimulation (tDCS) and D-cycloserine

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Official study title

Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2010
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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