Effectiveness of rTMS With Double-Cone-Coil in Patients With Major Depression (ACDC)

University of Regensburg (UR)

Status: Completed

Conditions: Depression

Treatments: Device: Placebo Stimulation; Device: Medial Frontal rTMS Double-Cone-Coil; Device: Left DLPFC Butterfly Coil

Study type: Interventional

Funder types: Other

Identifiers

NCT01460758

Uni-Reg-ACDC01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Episode of depression (unipolar or bipolar)( ICD-10)
• Female or male between 18 and 70 years old
• Skills to participate in all study procedures
• 18 or more points in the Hamilton rating scale or depression
• Stable antidepressant drugs
• Written informed consent

Exclusion criteria

• Clinically relevant unstable internal or neurological comorbidity
• Evidence of significant brain malformations or neoplasm, head injury
• Cerebral vascular events
• Neurodegenerative disorders affecting the brain or prior brain surgery
• Metal objects in and around body that can not be removed
• Pregnancy
• Alcohol or drug abuse
• Epilepsy or a pathological EEG
• Heart pacemaker
• High dose tranquillizers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Medial Frontal rTMS Double-Cone-Coil

Experimental group

Description:

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.

Treatment:

Device: Medial Frontal rTMS Double-Cone-Coil

Left DLPFC Butterfly Coil

Experimental group

Description:

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.

Treatment:

Device: Left DLPFC Butterfly Coil

Placebo Stimulation

Sham Comparator group

Description:

Sham Stimulation (Conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz,2000 Stimuli each session, 110% motor threshold

Treatment:

Device: Placebo Stimulation