|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | The University of New South Wales |
|---|---|
| Information provided by: | The University of New South Wales |
| ClinicalTrials.gov Identifier: | NCT01135953 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy Volunteers Brain Excitation |
Device: Transcranial Direct Current Stimulation (tDCS) Other: Transcranial direct Stimulation (tDCS) and D-cycloserine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
| Official Title: | Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS) |
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ARM 1 - CONTROL
Subject given tDCS every day of the week (5 sessions) at 2 mA.
|
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)
|
|
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).
|
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)
|
|
Experimental: ARM 3 - CYCLOSERINE
D-cycloserine (100 mg) given on the Monday and Thursday sessions, administering tDCS at 2 mA.
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Associate Professor Colleen Loo, School of Psychiatry, University of New South Wales |
| ClinicalTrials.gov Identifier: | NCT01135953 History of Changes |
| Other Study ID Numbers: | HREC09344 |
| Study First Received: | June 2, 2010 |
| Last Updated: | December 7, 2010 |
| Health Authority: | Australia: University of New South Wales Human Research Ethics Committee Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Brain excitation transcranial Direct Stimulation administration pattern |
|
Cycloserine Anti-Infective Agents, Urinary Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Renal Agents |
Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |