Trial of Transcranial Direct Current Stimulation (tDCS) Using Alternative Electrode Montages

NCT01021709 | Completed Phase 2 DMC

• 1 other identifier: 09343
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Among antidepressant treatments, ECT stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our current study of tDCS as a treatment for depression suggests that this technique has antidepressant effects and is safe, painless and well tolerated. However, not all patients may respond to this treatment in the way that it is currently administered and the concern of possible relapse in some patients who respond to tDCS has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether using alternative electrode montages can improve the antidepressant effects of tDCS in people suffering from depression.

Conditions

Major Depression

Keywords

depression; direct current stimulation; extracephalic electrode

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale for Depression (MADRS).

  Baseline (pre-treatment), post 8, post 15 and post 20 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment

  6 months

Secondary Outcomes (1)

• Inventory of Depressive Symptomatology (IDS-C).

  6 months

Study Arms (1)

tDCS with alternative electrode montage

EXPERIMENTAL

Treating major depression with either alternative tDCS electrode montage.

Device: tDCS (Eldith DC-Stimulator (CE certified))

Interventions

tDCS (Eldith DC-Stimulator (CE certified)) DEVICE

tDCS session lasting continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm = 35 cm2 \& 10 x 10 cm = 100 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).

Also known as: Eldith DC-Stimulator (CE certified)

tDCS with alternative electrode montage

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject completed study HREC 07305.
• Subject either did not reach remission at the end of trial (defined as MADRS score of ≤ 10) or suffered an early relapse (within a month of finishing the trial).

You may not qualify if:

• Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder current or within the past year); mental retardation.
• History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
• Inadequate response to ECT in the current episode of depression.
• Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
• Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
• Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
• Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
• Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

Black Dog Institute, University of New South Wales

Sydney, New South Wales, 2031, Australia

Location

Related Links

• Black Dog Institute website

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2009
• First Posted: November 30, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

AU (1)