Rationale and study design of a trial to assess rTMS add-on
value for the amelioration of negative symptoms of
schizophrenia (RADOVAN)

J 2022

Rationale and study design of a trial to assess rTMS add-on value for the amelioration of negative symptoms of schizophrenia (RADOVAN)

HEBEL, T., B. LANGGUTH, M. SCHECKLMANN, S. SCHOISSWOHL, S. STAUDINGER et. al.

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

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30215 Psychiatry

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

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

Abstract

V originále

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.

Citovat

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.

@article{2233426,
   author = {Hebel, T. and Langguth, B. and Schecklmann, M. and Schoisswohl, S. and Staudinger, S. and Schiller, A. and Ustohal, Libor and Svěrák, Tomáš and Horký, Martin and Kašpárek, Tomáš and Skront, T. and Hyza, M. and Poeppl, T. B. and Riester, M L and Schwemmer, L. and Zimmermann, S. and Sakreida, K.},
   article_location = {SAN DIEGO},
   article_number = {April 2022},
   doi = {http://dx.doi.org/10.1016/j.conctc.2022.100891},
   keywords = {Schizophrenia; Negative symptoms; Transcranial magnetic stimulation; TMS; Neuromodulation},
   language = {eng},
   issn = {2451-8654},
   journal = {CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS},
   title = {Rationale and study design of a trial to assess rTMS add-on value for the amelioration of negative symptoms of schizophrenia (RADOVAN)},
   url = {https://www.sciencedirect.com/science/article/pii/S2451865422000084?via%3Dihub},
   volume = {26},
   year = {2022}
}

TY  - JOUR
ID  - 2233426
AU  - Hebel, T. - Langguth, B. - Schecklmann, M. - Schoisswohl, S. - Staudinger, S. - Schiller, A. - Ustohal, Libor - Svěrák, Tomáš - Horký, Martin - Kašpárek, Tomáš - Skront, T. - Hyza, M. - Poeppl, T. B. - Riester, M L - Schwemmer, L. - Zimmermann, S. - Sakreida, K.
PY  - 2022
TI  - Rationale and study design of a trial to assess rTMS add-on value for the amelioration of negative symptoms of schizophrenia (RADOVAN)
JF  - CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS
VL  - 26
IS  - April 2022
SP  - 1-5
EP  - 1-5
PB  - ELSEVIER INC
SN  - 24518654
KW  - Schizophrenia
KW  - Negative symptoms
KW  - Transcranial magnetic stimulation
KW  - TMS
KW  - Neuromodulation
UR  - https://www.sciencedirect.com/science/article/pii/S2451865422000084?via%3Dihub
N2  - 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.
ER  -

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). \textit{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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