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

NCT ID: NCT01460758

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-11-30

Brief Summary

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.

Detailed 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.

Conditions

Depression

Study Design

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

Study Groups

Medial Frontal rTMS Double-Cone-Coil

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.

Group Type: EXPERIMENTAL

Medial Frontal rTMS Double-Cone-Coil

Intervention Type: 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.

Left DLPFC Butterfly Coil

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.

Group Type: EXPERIMENTAL

Left DLPFC Butterfly Coil

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Placebo Stimulation

Intervention Type: DEVICE

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

Interventions

Medial Frontal rTMS Double-Cone-Coil

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.

Intervention Type: DEVICE

Left DLPFC Butterfly Coil

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.

Intervention Type: DEVICE

Placebo Stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth, MD

Role: STUDY_DIRECTOR

University of Regensburg - Dep. of Psychiatry

Michael Landgrebe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg, Dpt of Psychiatry

Peter Kreuzer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg, Dpt of Psychiatry

Locations

University of Regensburg- Dept of Psychiatry

Regensburg, , Germany

Countries

Germany

Other Identifiers

Uni-Reg-ACDC01

Identifier Type: -

Identifier Source: org_study_id