Effectiveness of Theta-burst Stimulation (TBS) in Patients With Major Depression

University of Regensburg (UR)

Status: Completed

Conditions: Depression

Treatments: Device: High frequency rTMS; Device: Placebo Stimulation; Device: Thetaburst Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01240083

Uni-Reg-TB1

Details and patient eligibility

About

Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of the frontal cortex are used to modulate the neuronal excitability in patients with depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.

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, 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 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. Pilot data indicate that the mild effects of the rTMS could be increased by a special kind of TMS, the Theta-burst stimulation. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Episode of depression (unipolar or bipolar)( ICD-10)
• Female or male between 18 and 70 years
• Skills to participate in all study procedures
• 18 or more points in the Hamiliton 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: Double Blind

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61 participants in 3 patient groups

Thetaburst Stimulation

Experimental group

Description:

1: Thetaburst stimulation: right DLPFC continuous TBS followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 stimuli, 80% motorthreshold

Treatment:

Device: Thetaburst Stimulation

High frequency rTMS

Experimental group

Description:

2: Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC, 110% motor threshold, followed by 1000 stimuli of 10 Hz over the left DLPFC , 110% motorthreshold

Treatment:

Device: High frequency rTMS

Placebo Stimulation

Experimental group

Description:

3: Sham Stimulation (Sham coil): right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold

Treatment:

Device: Placebo Stimulation