Clinical trial NCT03953521: Neuronavigated TBS in Depression
Official title: Neuronavigated Theta Burst Stimulation in Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: HAMD
timeFrame: 4 weeks
Secondary outcomes:
measure: HAMD
timeFrame: 16 weeks
measure: MDI
timeFrame: 16 weeks
measure: PHQ-9
timeFrame: 16 weeks
measure: WHOQOL-BREF
timeFrame: 16 weeks
measure: CGI
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Regensburg
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hebel T, Gollnitz A, Schoisswohl S, Weber FC, Abdelnaim M, Wetter TC, Rupprecht R, Langguth B, Schecklmann M. A direct comparison of neuronavigated and non-neuronavigated intermittent theta burst stimulation in the treatment of depression. Brain Stimul. 2021 Mar-Apr;14(2):335-343. doi: 10.1016/j.brs.2021.01.013. Epub 2021 Jan 22.