Neuronavigated TBS in Depression

Study Overview
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Brief Summary
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In this randomized controlled trial we will treat 80 patients with depression with intermittent theta burst stimulation in two parallel arms. Both arms are active interventions differing with respect to positioning of the treatment coil - one arm with neuronavigation and one arm with targeting according to EEG Position representing the left dorsolateral prefrontal cortex. Randomisation will be balanced for in- and out-patients and for the treatment arms.

Detailed Description
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Intermittent Theta burst Stimulation (iTBS) is a specific type of repetitive transcranial magnetic Stimulation (rTMS). rTMS of the left prefrontal cortex was shown to be effective in the treatment of Depression. Recent studies showed that iTBS probably is as effective as rTMS. One possibility to increase to efficacy of rTMS/iTBS is to use neuronavigation. With neuronavigation the coil Position can be targeted with an accuracy in the range of millimeters. Furthermore the Stimulation Position can be ensured during one single session and over the course of the daily Treatments. The aim of the present study is to investigate the benefit of neuronavigation in the Treatment of Depression with iTBS by using two arms one with targeting the Stimulation site with neuronavigation and one by using the EEG Position F3 as target by using head caps for marking the position.

Official Title
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Neuronavigated Theta Burst Stimulation in Depression

Conditions
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Depression

Intervention / Treatment
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* Device: intermittent Theta burst stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unipolar or bipoloar depressive Episode according to ICD-10 at least moderate Depression according to Hamilton Depression Rating Scale or ICD-10 if applicable stable medication with psychoactive compounds for out-patients if applicable no or stable Treatment for Depression during the course of the Trial residence in Germany and mother tongue German written informed consent Exclusion Criteria: Meeting the contraindications for transcranial magnetic Stimulation or magnetic resonance Imaging (electic devices or metal implants in the Body, e.g. cardiac pace maker, Insulin ppump) neurological disorders (e.g. cerebrovascular Events, neurodegenerative disorder, epilepsy, brain malformation, severe head Trauma) addictive disorder with consumption in the last two years regular intake of benzodiazepines participation in another study parallel to the Trial pregnancy or breastfeading period psychiatric confinement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: navigated<br>Positioning of the coil according to neuronavigation (Mylius et al., 2013, Definition of DLPFC and M1 according to anatomical landmarks for navigated brain stimulation: Inter-rater reliability, accuracy, and influence of gender and Age, NeuroImage 78, 224-232). | Device: intermittent Theta burst stimulation<br>* Stimulation of the left dorsolateral prefrontal Cortex with a specific repetitive transcranial magnetic Stimulation protocol (intermittent Theta burst Stimulation) according to Blumberger et al., 2018, Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692.<br>|
| Active Comparator: F3<br>Positioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap). | Device: intermittent Theta burst stimulation<br>* Stimulation of the left dorsolateral prefrontal Cortex with a specific repetitive transcranial magnetic Stimulation protocol (intermittent Theta burst Stimulation) according to Blumberger et al., 2018, Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD | Hamilton Depression Rating Scale | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD | Hamilton Depression Rating Scale | 16 weeks | 
| MDI | Major Depression Inventory | 16 weeks | 
| PHQ-9 | 9-question depression scale from the Patient Health Questionnaire | 16 weeks | 
| WHOQOL-BREF | WHO Quality of life scale (abbreviated Version) | 16 weeks | 
| CGI | Clincial Global Impression change | 16 weeks |