Neuronavigated TBS in Depression (neuronaviTBS)

University of Regensburg (UR)

Status: Terminated

Conditions: Depression

Treatments: Device: intermittent Theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03953521

18-1231-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

navigated

Experimental group

Description:

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).

Treatment:

Device: intermittent Theta burst stimulation

F3

Active Comparator group

Description:

Positioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap).

Treatment:

Device: intermittent Theta burst stimulation