Neuronavigated TBS in Depression

Not Applicable

Terminated

• Conditions: Depression
• Interventions: Device: intermittent Theta burst stimulation

• Registration Number: NCT03953521
• Lead Sponsor: University of Regensburg

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.

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Study Start: 2019-06-01
• Status Verified: 2020-05
• Primary Completion: 2020-05-27
• Study Completion: 2020-05-27
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
F3	intermittent Theta burst stimulation	Positioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap).
navigated	intermittent Theta burst stimulation	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).

Primary Outcome Measures

Name	Time	Method
HAMD	4 weeks	Hamilton Depression Rating Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, University of Regensburg; 🇩🇪 Regensburg, Germany