Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression
Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression - Effect on Clinical and Neurophysiological Parameters
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Munich, Germany, 80336
- Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: 1
anodal tDCS
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real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
Other Names:
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SHAM_COMPARATOR: 2
Sham tDCS
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real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hamilton Psychiatric Rating Scale for Depression (HRSD-24)
Time Frame: 6
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6
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Beck depression Inventory (BDI) Clinical Global Impression (CGI) Mini-Mental-Status-Test (MMST) Verbal Learning and Memory Test (VLMT) Regensburger Word Fluency Test (RWT)
Time Frame: 4
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4
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Collaborators and Investigators
Investigators
- Principal Investigator: Frank Padberg, MD, PhD, Dept. of Psychiatry, Ludwig-Maximilians-University Munich
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01/2007
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