Depression
Conditions
Brief summary
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
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.
Interventions
DEVICEintermittent Theta burst stimulation
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.
Sponsors
University of Regensburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAMD | 4 weeks | Hamilton Depression Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAMD | 16 weeks | Hamilton Depression Rating Scale |
| MDI | 16 weeks | Major Depression Inventory |
| PHQ-9 | 16 weeks | 9-question depression scale from the Patient Health Questionnaire |
| WHOQOL-BREF | 16 weeks | WHO Quality of life scale (abbreviated Version) |
| CGI | 16 weeks | Clincial Global Impression change |
Countries
Germany
Outcome results
None listed