Methods to Enhance Transcranial Direct Stimulation (tDCS)

NCT ID: NCT01135953

Last Updated: 2010-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-07-31

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.

Conditions

Healthy Volunteers; Brain Excitation

Keywords

Brain excitation; transcranial Direct Stimulation; administration pattern

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

ARM 1 - CONTROL

Subject given tDCS every day of the week (5 sessions) at 2 mA.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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).

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).

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

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).

ARM 3 - CYCLOSERINE

D-cycloserine (100 mg) given on the Monday and Thursday sessions, administering tDCS at 2 mA.

Group Type: EXPERIMENTAL

Transcranial direct Stimulation (tDCS) and D-cycloserine

Intervention Type: 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.

Interventions

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).

Intervention Type: 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).

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

tDCS (Eldith DC-Stimulator (CE certified); Eldith DC-Stimulator (CE certified); tDCS - Eldith DC-Stimulator (CE certified); D-cycloserine, Seromycin Pulvules, 100 mg

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of New South Wales

OTHER

Sponsor Role: lead

Responsible Party

School of Psychiatry, University of New South Wales

Locations

Black Dog Institute, University of New South Wales

Sydney, New South Wales, Australia

Countries

Australia

Related Links

http://www.blackdoginstitute.org.au

Black Dog Institute website

Other Identifiers

HREC09344

Identifier Type: -

Identifier Source: org_study_id