HEBEL, T., B. LANGGUTH, M. SCHECKLMANN, S. SCHOISSWOHL, S. STAUDINGER, A. SCHILLER, Libor USTOHAL, Tomáš SVĚRÁK, Martin HORKÝ, Tomáš KAŠPÁREK, T. SKRONT, M. HYZA, T. B. POEPPL, M L RIESTER, L. SCHWEMMER, S. ZIMMERMANN and K. SAKREIDA. Rationale and study design of a trial to assess rTMS add-on value for the amelioration of negative symptoms of schizophrenia (RADOVAN). CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS. SAN DIEGO: ELSEVIER INC, 2022, vol. 26, April 2022, p. 1-5. ISSN 2451-8654. Available from: https://dx.doi.org/10.1016/j.conctc.2022.100891.
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Basic information
Original name Rationale and study design of a trial to assess rTMS add-on value for the amelioration of negative symptoms of schizophrenia (RADOVAN)
Authors HEBEL, T. (guarantor), B. LANGGUTH, M. SCHECKLMANN, S. SCHOISSWOHL, S. STAUDINGER, A. SCHILLER, Libor USTOHAL (203 Czech Republic, belonging to the institution), Tomáš SVĚRÁK (203 Czech Republic, belonging to the institution), Martin HORKÝ (203 Czech Republic, belonging to the institution), Tomáš KAŠPÁREK (203 Czech Republic, belonging to the institution), T. SKRONT (203 Czech Republic), M. HYZA (203 Czech Republic), T. B. POEPPL, M L RIESTER, L. SCHWEMMER, S. ZIMMERMANN and K. SAKREIDA.
Edition CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, SAN DIEGO, ELSEVIER INC, 2022, 2451-8654.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30215 Psychiatry
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 1.500
RIV identification code RIV/00216224:14110/22:00127216
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1016/j.conctc.2022.100891
UT WoS 000820423400007
Keywords in English Schizophrenia; Negative symptoms; Transcranial magnetic stimulation; TMS; Neuromodulation
Tags 14110222
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 22/11/2022 10:15.
Abstract
Background: Schizophrenia is a severe and often difficult to treat psychiatric illness. In many patients, negative symptoms dominate the clinical picture. Meta-analysis has suggested moderate, but significant effects of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) on these symptoms. For treatment of depression a much shorter protocol - intermittent theta burst stimulation (iTBS) - has shown to be non-inferior to conventional high-frequency rTMS. This randomized, sham-controlled, rater-blinded clinical trial assesses the effects of conventional HF-rTMS as well as of iTBS of the left dorsolateral prefrontal cortex in comparison with sham. Methods: The study will be conducted at two psychiatric university hospitals in Germany and at two in the Czech Republic. Assuming an effect size of 0.64 to be detected with a power of 80%, the calculated sample size is 90 patients. Primary outcome will be the difference in the Scale for the Assessment of Negative Symptoms (SANS) score between each active arm and the sham arm at end of treatment. In addition, the trial investigates effects on depressive symptoms, cognitive performance and cigarette smoking. Recording magnetic resonance imaging (MRI) and electroencephalography (EEG) data will serve to assess whether treatment success can be predicted by neural markers and is related to specific neurobiological changes. Discussion: This is a clinical trial directly comparing 10 Hz-rTMS and iTBS in a sham-controlled manner in treating negative symptoms of schizophrenia. If successful, this would present an interesting treatment option for a chronic and severe condition that can be applied at most psychiatric hospitals and only takes up a few minutes per day.
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