Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression

NCT ID: NCT00667680

Last Updated: 2009-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-11-30

Brief Summary

tDCS applies a small amount of direct electric current (DC) to the brain by means of two electrodes: the one is an active electrode, localized on the effective site, and the other is a reference electrode, localized on some "silent" part of the body. Anodal transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPFC) has been associated with working memory enhancement and improvement of mood. This study will investigate the possible antidepressant effects of tDCS in patients with therapy resistant major depressive episodes.

Detailed Description

Transcranial direct current stimulation (tDCS) is a non-invasive method that shifts membrane potential towards hypo- or hyperpolarization and therefore leads to functional changes in a discrete area of the cerebral cortex.

Neurophysiological studies have shown that slow changes in cortical scalp potential reflect overall activity of cortical neuronal networks. These scalp potentials reflect shifts in membrane potentials of the cortical neurons. Over the past 7 years tDCS has evolved as an important tool to non-invasively manipulate specific neural circuits of the human brain.

The purpose of this study is an investigation of tDCS applied to 20 therapy-resistance major depressive patients. Our hypothesis is that tDCS may exert an antidepressant effect and/or enhances the medication effect. tDCS will be examined in the framework of a placebo-controlled clinical pilot-study investigating effectiveness, safety and influence on EEG parameters. Patients will receive anodal DC stimulation or sham stimulation (extra designed placebo-stimulator) in a double-blind design over 10 days for each condition. Outcomes will be evaluated using several clinical, psychiatric and neuropsychological rating scales.

Conditions

Therapy Resistant Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

anodal tDCS

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator

Intervention Type: DEVICE

real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)

2

Sham tDCS

Group Type: SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator

Intervention Type: DEVICE

real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)

Interventions

Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator

real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)

Intervention Type: DEVICE

Other Intervention Names

Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)

Eligibility Criteria

Inclusion Criteria

• Age 18-75 years
• At least moderate major depressive episode (DSM IV criteria).
• Stable total pre-treatment Hamilton Rating Scale for Depression score ≥18
• Therapy-resistance during current depressive episode (according to ATHF).
• The patient must be in the condition to understand the patient-information, as well as the necessary examinations. He/she must be able to give a written consent.
• Stable antidepressant medication, that is retained during the study- duration, from at least three weeks before the begin of the study.

Exclusion Criteria

• Existence of a care/legal incapacity
• Existing pregnancy
• Severe psychiatric illness (with exception of affective disorder)
• Acute suicidality
• Drug-, medication- or alcohol dependence
• Dementia according to DSM IV / ICD 10-criterions
• Severe TBI in the anamnesis
• Indications of structural damage of the basal ganglia or the brain stem
• Severe neurological disorders (e.g. M. Parkinson, epilepsy, discus-prolapse, dementia, systemic neurological illnesses, normal pressure hydrocephalus, cerebrovascular diseases, elevated intracranial pressure, in the last 6 months, polyneuropathies).
• Severe other medical conditions, like manifest arterial hypertonia, severe heart disease, pacemakers, respiratory failure, malignant illnesses all type, also in the history, active infectious diseases, skeletal disorders (like M. Paget, osteoporosis with spontaneous fractures, fresh fractures)
• Other circumstances, that speaks against a participation of the patient pinion of MD at this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Psychiatry, Ludwig-Maximilians-University Munich

Principal Investigators

Frank Padberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Psychiatry, Ludwig-Maximilians-University Munich

Locations

Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich

Munich, , Germany

Countries

Germany

Related Links

http://psywifo.klinikum.uni-muenchen.de/forschung/tms/indexeng.html

Related Info

Other Identifiers

01/2007

Identifier Type: -

Identifier Source: org_study_id