Trial of Transcranial Direct Current Stimulation (tDCS) Using Alternative Electrode Montages
This study is currently recruiting participants.
Verified February 2013 by The University of New South Wales
Sponsor:
The University of New South Wales
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01021709
First received: November 27, 2009
Last updated: February 3, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression |
Device: tDCS (Eldith DC-Stimulator (CE certified)) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by The University of New South Wales:
Primary Outcome Measures:
- Montgomery Asberg Depression Rating Scale for Depression (MADRS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Inventory of Depressive Symptomatology (IDS-C). [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: tDCS with alternative electrode montage
Treating major depression with either alternative tDCS electrode montage.
|
Device: tDCS (Eldith DC-Stimulator (CE certified))
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).
Other Name: Eldith DC-Stimulator (CE certified)
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject met inclusion criteria for study HREC 07305 (a sham controlled study of transcranial direct current stimulation (tDCS) as a treatment for depression).
- 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).
Exclusion Criteria:
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021709
Contacts
| Contact: Angelo Alonzo, PhD | +61 2 9382 3720 | a.alonzo@unsw.edu.au |
| Contact: Donel Martin, PhD | +61 2 9382 9261 | donel.martin@unsw.edu.au |
Locations
| Australia, New South Wales | |
| Black Dog Institute, University of New South Wales | Recruiting |
| Sydney, New South Wales, Australia, 2031 | |
| Principal Investigator: Colleen Loo, MBBS | |
Sponsors and Collaborators
The University of New South Wales
More Information
Additional Information:
No publications provided
| Responsible Party: | Colleen Loo, Professor, The University of New South Wales |
| ClinicalTrials.gov Identifier: | NCT01021709 History of Changes |
| Other Study ID Numbers: | 09343 |
| Study First Received: | November 27, 2009 |
| Last Updated: | February 3, 2013 |
| Health Authority: | Australia: University of New South Wales Human Research Ethics Committee Australia: Therapeutic Goods Administration |
Keywords provided by The University of New South Wales:
|
depression direct current stimulation extracephalic electrode |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013