Rationale and study design of a trial to assess rTMS add-on value for the amelioration of negative symptoms of schizophrenia (RADOVAN)
Status PubMed-not-MEDLINE Jazyk angličtina Země Nizozemsko Médium electronic-ecollection
Typ dokumentu časopisecké články
PubMed
35128142
PubMed Central
PMC8804178
DOI
10.1016/j.conctc.2022.100891
PII: S2451-8654(22)00008-4
Knihovny.cz E-zdroje
- Klíčová slova
- Negative symptoms, Neuromodulation, Schizophrenia, TMS, Transcranial magnetic stimulation,
- Publikační typ
- časopisecké články MeSH
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. TRIAL REGISTRATION NUMBER: This trial has been registered at clinicaltrials.gov, Identifier: NCT04318977. DATA DISSEMINATION: Results from the trial shall be published in peer-reviewed journals and presented at meetings and conferences.
Zobrazit více v PubMed
Meltzer H.Y., Pringuey D. Treatment-resistant schizophrenia: the importance of early detection and treatment. Introduction. J. Clin. Psychopharmacol. 1998;18(2 Suppl 1):1S. PubMed
Vita A., Minelli A., Barlati S., Deste G., Giacopuzzi E., Valsecchi P., et al. Treatment-Resistant schizophrenia: genetic and neuroimaging correlates. Front. Pharmacol. 2019;10:402. PubMed PMC
Remington G., Foussias G., Fervaha G., Agid O., Takeuchi H., Lee J., et al. Treating negative symptoms in schizophrenia: an update. Curr. Treat. Options Psychiatr. 2016;3:133–150. PubMed PMC
Lefaucheur J.P., Aleman A., Baeken C., Benninger D.H., Brunelin J., Di Lazzaro V., et al. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): an update (2014-2018) Clin. Neurophysiol. 2020;131(2):474–528. PubMed
Hill K., Mann L., Laws K.R., Stephenson C.M., Nimmo-Smith I., McKenna P.J. Hypofrontality in schizophrenia: a meta-analysis of functional imaging studies. Acta Psychiatr. Scand. 2004;110(4):243–256. PubMed
Dlabac-de Lange J.J., Liemburg E.J., Bais L., Renken R.J., Knegtering H., Aleman A. Effect of rTMS on brain activation in schizophrenia with negative symptoms: a proof-of-principle study. Schizophr. Res. 2015;168(1–2):475–482. PubMed
Wobrock T., Guse B., Cordes J., Wolwer W., Winterer G., Gaebel W., et al. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol. Psychiatr. 2015;77(11):979–988. PubMed
Aleman A., Enriquez-Geppert S., Knegtering H., Dlabac-de Lange J.J. Moderate effects of noninvasive brain stimulation of the frontal cortex for improving negative symptoms in schizophrenia: meta-analysis of controlled trials. Neurosci. Biobehav. Rev. 2018;89:111–118. PubMed
Huang Y.Z., Edwards M.J., Rounis E., Bhatia K.P., Rothwell J.C. Theta burst stimulation of the human motor cortex. Neuron. 2005;45(2):201–206. PubMed
Blumberger D.M., Vila-Rodriguez F., Thorpe K.E., Feffer K., Noda Y., Giacobbe P., et al. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018;391(10131):1683–1692. PubMed
Zhao S., Kong J., Li S., Tong Z., Yang C., Zhong H. Randomized controlled trial of four protocols of repetitive transcranial magnetic stimulation for treating the negative symptoms of schizophrenia. Shanghai. Arch. Psychiatr. 2014;26(1):15–21. PubMed PMC
Wang L., Chen X., Wu Y., He K., Xu F., Xiao G., et al. Intermittent theta burst stimulation (iTBS) adjustment effects of schizophrenia: results from an exploratory outcome of a randomized double-blind controlled study. Schizophr. Res. 2020;216:550–553. PubMed
Koutsouleris N., Wobrock T., Guse B., Langguth B., Landgrebe M., Eichhammer P., et al. Predicting response to repetitive transcranial magnetic stimulation in patients with schizophrenia using structural magnetic resonance imaging: a multisite machine learning analysis. Schizophr. Bull. 2018;44(5):1021–1034. PubMed PMC
Boutros N.N., Mucci A., Diwadkar V., Tandon R. Negative symptoms in schizophrenia. Clin. Schizophrenia Relat. Psychoses. 2014;8(1):28–35B. PubMed
Khanna A., Pascual-Leone A., Michel C.M., Farzan F. Microstates in resting-state EEG: current status and future directions. Neurosci. Biobehav. Rev. 2015;49:105–113. PubMed PMC
Michel C.M., Koenig T. EEG microstates as a tool for studying the temporal dynamics of whole-brain neuronal networks: a review. Neuroimage. 2018;180(Pt B):577–593. PubMed
Tomescu M.I., Rihs T.A., Roinishvili M., Karahanoglu F.I., Schneider M., Menghetti S., et al. Schizophrenia patients and 22q11.2 deletion syndrome adolescents at risk express the same deviant patterns of resting state EEG microstates: a candidate endophenotype of schizophrenia. Schizophr. Res. Cognit. 2015;2(3):159–165. PubMed PMC
Rieger K., Diaz Hernandez L., Baenninger A., Koenig T. 15 Years of microstate research in schizophrenia - where are we? A meta-analysis. Front. Psychiatr. 2016;7:22. PubMed PMC
Orliac F., Naveau M., Joliot M., Delcroix N., Razafimandimby A., Brazo P., et al. Links among resting-state default-mode network, salience network, and symptomatology in schizophrenia. Schizophr. Res. 2013;148(1–3):74–80. PubMed
Goodkind M., Eickhoff S.B., Oathes D.J., Jiang Y., Chang A., Jones-Hagata L.B., et al. Identification of a common neurobiological substrate for mental illness. JAMA Psychiatr. 2015;72(4):305–315. PubMed PMC
Peters H., Shao J., Scherr M., Schwerthoffer D., Zimmer C., Forstl H., et al. More consistently altered connectivity patterns for cerebellum and medial temporal lobes than for amygdala and striatum in schizophrenia. Front. Hum. Neurosci. 2016;10:55. PubMed PMC
Kikuchi M., Koenig T., Wada Y., Higashima M., Koshino Y., Strik W., et al. Native EEG and treatment effects in neuroleptic-naive schizophrenic patients: time and frequency domain approaches. Schizophr. Res. 2007;97(1–3):163–172. PubMed
Levit-Binnun N., Litvak V., Pratt H., Moses E., Zaroor M., Peled A. Differences in TMS-evoked responses between schizophrenia patients and healthy controls can be observed without a dedicated EEG system. Clin. Neurophysiol. 2010;121(3):332–339. PubMed
Noda Y., Barr M.S., Zomorrodi R., Cash R.F.H., Rajji T.K., Farzan F., et al. Reduced short-latency afferent inhibition in prefrontal but not motor cortex and its association with executive function in schizophrenia: a combined TMS-EEG study. Schizophr. Bull. 2018;44(1):193–202. PubMed PMC
Kaskie R.E., Ferrarelli F. Investigating the neurobiology of schizophrenia and other major psychiatric disorders with Transcranial Magnetic Stimulation. Schizophr. Res. 2018;192:30–38. PubMed
Prikryl R., Ustohal L., Kucerova H.P., Kasparek T., Jarkovsky J., Hublova V., et al. Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. Prog. Neuro-Psychopharmacol. Biol. Psychiatry. 2014;49:30–35. PubMed
Cordes J., Falkai P., Guse B., Hasan A., Schneider-Axmann T., Arends M., et al. Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study. Eur. Arch. Psychiatr. Clin. Neurosci. 2009;259(Suppl 2):S189–S197. PubMed
Kreuzer P.M., Poeppl T.B., Bulla J., Schlee W., Lehner A., Langguth B., et al. A proof-of-concept study on the combination of repetitive transcranial magnetic stimulation and relaxation techniques in chronic tinnitus. J. Neural. Transm. 2016;123(10):1147–1157. PubMed
ClinicalTrials.gov
NCT04318977