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Continuous theta burst TMS as an add-on treatment for bipolar depression, design for a multicenter randomized sham-controlled trial.

Kaat Hebbrect1, 2*, Violette Coppens1, 2, Manuel Morrens1, 2, Dieter Zeeuws3, 4*, Chris Baeken3, 5, 6 and Bernard Sabbe1, 2
  • 1 Collaborative Antwerp Psychiatric Research Institute, University of Antwerp, Belgium
  • 2 Psychiatric Hospital Duffel, VZW Emmaüs, Belgium
  • 3 University Hospital Brussels, Belgium
  • 4 Vrije Universiteit Brussel, Belgium
  • 5 Free University of Brussels, Belgium
  • 6 Ghent University, Belgium

Transcranial magnetic stimulation (TMS) is an accepted, evidence-based treatment option for the treatment of depressive episodes in patients with major depressive disorder. However, due to the lack of TMS studies in bipolar depressed patients, the antidepressant efficacy in bipolar depression remains unclear. This study therefore aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. Theta burst stimulation, a relatively new form of TMS, is assumed to have similar clinical effects as the more regular rTMS parameters (high frequency rTMS administered to the left dorsolateral prefrontal cortex and low frequency rTMS administered to the right dorsolateral prefrontal cortex), but it has the advantage that it requires less stimulation time to produce longer lasting effects in the human cerebral cortex. Objectives Primary objectives - To investigate the efficacy of continuous theta burst TMS as an add-on treatment in bipolar depression (type I/II). Secondary objectives - To investigate the effect of continuous theta burst TMS as an add-on treatment on cognitive and psychomotor symptoms in bipolar depression (type I/II). - To investigate the effect of continuous theta burst TMS as an add-on treatment on levels of biological markers of bipolar depression (for example neurotrophic factors or cytokine levels). - To investigate the possible predictive value of cognitive and psychomotor symptoms and biological markers for response to cTBS TMS treatment in bipolar depression (type I/II). - To investigate the safety profile of cTBS TMS in bipolar depression (type I/II). Overview of study design (cfr image 1) Flowchart of the TMS procedure. Baseline measurements will be assessed at T0. cTBS treatment is spread over four succeeding days in week 2. All participants will be randomized to receive real or sham CTBS. A second assessment (T1) will be exactly one week (+/- 1 day) after T0 and a third assessment will be exactly two weeks (+/- 1 day) after T0.

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Keywords: depressive episode, bipolar (affective/mood) disorders, add-on, rTMS (repetitive Transcranial Magnetic Stimulation), Continuous Theta Burst Stimulation (cTBS), RCT (randomised controlled trial)

Conference: Belgian Brain Congress 2018 — Belgian Brain Council, LIEGE, Belgium, 19 Oct - 19 Oct, 2018.

Presentation Type: e-posters

Topic: NOVEL STRATEGIES FOR NEUROLOGICAL AND MENTAL DISORDERS: SCIENTIFIC BASIS AND VALUE FOR PATIENT-CENTERED CARE

Citation: Hebbrect K, Coppens V, Morrens M, Zeeuws D, Baeken C and Sabbe B (2019). Continuous theta burst TMS as an add-on treatment for bipolar depression, design for a multicenter randomized sham-controlled trial.. Front. Neurosci. Conference Abstract: Belgian Brain Congress 2018 — Belgian Brain Council. doi: 10.3389/conf.fnins.2018.95.00041

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Received: 14 Aug 2018; Published Online: 17 Jan 2019.

* Correspondence:
Dr. Kaat Hebbrect, Collaborative Antwerp Psychiatric Research Institute, University of Antwerp, Antwerp, Antwerp, 2610, Belgium, Kaat.Hebbrecht@Emmaus.be
Dr. Dieter Zeeuws, University Hospital Brussels, Brussels, Belgium, dieter.zeeuws@uzbrussel.be