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Repetitive Transcranial Magnetic Stimulation (rTMS) is used to modulate the neuronal excitability in patients with depression. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be superior to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.
Depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy levels and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday's responsibilities, at its worst, depression can lead to suicide. Depression can be reliably diagnosed in primary care. Antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80% of those affected and can be delivered in primary care.
In patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability disorders. Mild antidepressant effects of rTMS applied to the left sided dorsolateral prefrontal cortex (DLPFC) using a standard butterfly coil can possibly be increased by a different stimulation protocol over the medial frontal cortex using a double-cone-coil. First hints to effectiveness of this treatment arise from case reports and therefore need replication and comparability to conventional stimulation protocols. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be more effective to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medial Frontal rTMS Double-Cone-Coil | Experimental | High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodmann area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold. |
|
| Left DLPFC Butterfly Coil | Experimental | High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 10 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold. |
|
| Placebo Stimulation | Sham Comparator | Sham Stimulation (Conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz,2000 Stimuli each session, 110% motor threshold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial Frontal rTMS Double-Cone-Coil | Device | High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodmann area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19) | Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Alertness (Baseline versus end of treatment/ day 19) | Day 19 | |
| Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19) | Day 19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth, MD | University of Regensburg - Dep. of Psychiatry | Study Director |
| Michael Landgrebe, MD | University of Regensburg, Dpt of Psychiatry | Principal Investigator |
| Peter Kreuzer, MD | University of Regensburg, Dpt of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regensburg- Dept of Psychiatry | Regensburg | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Left DLPFC Butterfly Coil | Device | High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 10 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold. |
|
| Placebo Stimulation | Device | Sham Stimulation (conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz, 2000 Stimuli each session, 110% motor threshold |
|
| Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19) | Day 19 |
| Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19) | Day 19 |
| Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19) | Day 19 |
| Change in the Alertness (Baseline versus follow-up I/ day 47) | Day 47 |
| Change in the Alertness (Baseline versus follow-up II/ day 75) | Day 75 |
| Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up I/ day 47) | Day 47 |
| Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up II/ day 75) | Day 75 |
| Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47) | Day 47 |
| Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75) | Day 75 |
| Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47) | Day 47 |
| Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75) | Day 75 |
| Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47) | Day 47 |
| Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75) | Day 75 |