Treatment of auditory hallucinations in schizophrenia with bilateral theta burst stimulation - renewal proposal.
Biological Psychiatry
Final Report Abstract
People suffering from schizophrenia frequently report auditory verbal hallucinations (AvH), which are often severely distressing, can considerably restrict participation in social life, and can result in violence or even suicidality. Treatment as usual is the prescription of antipsychotic medication, but in 20% to 30% of the patients AvH persist. In addition, these drugs may be associated with severe side effects, which leads to low treatment adherence. For this reason, the development of alternative, well-tolerated forms of treatment is necessary. A promising candidate for this is transcranial magnetic stimulation (TMS), in which the nerve cells of the brain are stimulated from the outside through the skull (= transcranially) using magnetic impulses. Depending on the parameters of the pulses, the activity of the stimulated nerve cells can either be boosted or reduced. Studies investigating TMS for the treatment of AvH showed contradictory results. One reason for this is the low comparability of the studies, as, for example, the number of treatment sessions, the stimulation parameters or the duration of treatment periods differed. Nevertheless, meta-analysis concluded a certain effectiveness of TMS in the treatment of AvH but the final proof of efficacy, which is provided in the context of so-called confirmatory studies, was lacking. With our multicentre, randomized, placebo-controlled clinical study we wanted to close this gap. Our study was conducted under the overall direction of Prof. Plewnia, Department of Psychiatry and Psychotherapy at the University of Tübingen and was supported by six other university hospitals (LMU Munich, BKH Augsburg, LVR Düsseldorf, Ulm, Heidelberg and Rostock). Overall, 138 patients took part in the study. Within a treatment phase of three weeks, participants received 15 TMS treatment sessions in the form of continuous theta burst stimulation (cTBS), which is a new, time-saving variant of TMS. In each cTBS session, both hemispheres of the brain were stimulated at temporo-parietal cortex. However, in order to be able to objectively assess the effectiveness of the procedure, only half of all participants received active TMS, while the other half received sham stimulation. During sham condition, all procedures were identical to active cTBS, however, the technical equipment ensures that the patients did not receive any magnetic pulses, although they could hear the noise typical of TMS. Whether a patient received active cTBS or sham treatment was determined randomly. The statistical analysis focused on the change in AvH (measured using a standard psychiatric scale) between the start and end of treatment in both groups. The results of our study show that the treatment effects in the active cTBS group were significantly greater compared to the sham group and that the side effects were very low. Thus, cTBS represents a safe and effective treatment option for patients with medication-resistant auditory hallucinations.
Publications
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Treatment of auditory hallucinations with bilateral theta burst stimulation (cTBS): protocol of a randomized, double-blind, placebo-controlled, multicenter trial. European Archives of Psychiatry and Clinical Neuroscience, 268(7), 663-673.
Plewnia, Christian; Brendel, Bettina; Schwippel, Tobias; Martus, Peter; Cordes, Joachim; Hasan, Alkomiet & Fallgatter, Andreas J.
