Examining transcranial random noise stimulation as an add-on treatment for persistent symptoms in schizophrenia (STIM’Zo): a study protocol for a multicentre, double-blind, randomized sham-controlled clinical trial

Trials

David Szekely¹  Wissam El-Hage²  Sonia Dollfus³  Jerome Attal⁴  Michel Benoit⁵  Pierre Michel Llorca⁶  Filipe Galvao⁷  Jerome Brunelin⁸  Marine Mondino⁸  Emmanuel Poulet⁹  Marion Plaze^1,10  Laurent Magaud^1,11  Anne Marie Schott-Pethelaz^1,12  Julie Haesebaert^1,12  Marie-Françoise Suaud-Chagny^1,13  Eric Fakra^1,14  Marie Chupin^1,15  Renaud Jardri^1,16 

[1] CH Princess Grace, MC-98000, Monaco, Monaco;CHRU de Tours, CIC 1415, INSERM, Tours; UMR 1253, iBrain, Université de Tours, INSERM, F-37044, Tours, France;CHU Caen, F-14033, Caen, France;CHU Montpellier, F-34295, Montpellier, France;CHU Nice, F-06001, Nice, France;CHU de Clermont-Ferrand, F-63003, Clermont-Ferrand, France;Centre Hospitalier Le Vinatier, PSYR2 team, Bat 416 – 1st floor; 95 boulevard Pinel, 69678, F-69500, Bron cedex, France;Centre Hospitalier Le Vinatier, PSYR2 team, Bat 416 – 1st floor; 95 boulevard Pinel, 69678, F-69500, Bron cedex, France;INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, F-69000, Lyon, France;Lyon 1 University, F-69000, Villeurbanne, France;Université Jean Monnet Saint Etienne, F-42000, Saint Etienne, France;Centre Hospitalier Le Vinatier, PSYR2 team, Bat 416 – 1st floor; 95 boulevard Pinel, 69678, F-69500, Bron cedex, France;INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, F-69000, Lyon, France;Lyon 1 University, F-69000, Villeurbanne, France;Université Jean Monnet Saint Etienne, F-42000, Saint Etienne, France;Psychiatric emergency service, Hospices civils de Lyon, F-69005, Lyon, France;GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, F-75014, Paris, France;Université de Paris, F-75005, Paris, France;Hospices Civils de Lyon, Pôle Santé Publique, Service Recherche et Epidémiologie Cliniques, F-69003, Lyon, France;Hospices Civils de Lyon, Pôle Santé Publique, Service Recherche et Epidémiologie Cliniques, F-69003, Lyon, France;Research on Healthcare Performance RESHAPE, INSERM U1290, Université Claude Bernard Lyon 1, Villeurbanne, France;INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, F-69000, Lyon, France;Lyon 1 University, F-69000, Villeurbanne, France;Université Jean Monnet Saint Etienne, F-42000, Saint Etienne, France;INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, F-69000, Lyon, France;Lyon 1 University, F-69000, Villeurbanne, France;Université Jean Monnet Saint Etienne, F-42000, Saint Etienne, France;CHU de Saint Etienne, F-42000, Saint Etienne, France;Paris Brain Institute – Institut du Cerveau (ICM), Inserm U 1127, CNRS UMR 7225, Sorbonne Université, F-75013, Paris, France;CATI Multicenter Neuroimaging Platform, F-75000, Paris, France;University in Lille, INSERM U1172, CHU Lille, Lille Neuroscience & Cognition Research Centre, Plasticity & SubjectivitY (PSY) team, CURE Platform, Lille, France;

关键词: Schizophrenia;    Noninvasive brain stimulation;    tDCS;    tRNS;    Hallucination;    Negative symptoms;   

DOI  :  10.1186/s13063-021-05928-9

来源: Springer

【 摘 要 】

BackgroundOne out of three patients with schizophrenia failed to respond adequately to antipsychotics and continue to experience debilitating symptoms such as auditory hallucinations and negative symptoms. The development of additional therapeutic approaches for these persistent symptoms constitutes a major goal for patients. Here, we develop a randomized-controlled trial testing the efficacy of high-frequency transcranial random noise stimulation (hf-tRNS) for the treatment of resistant/persistent symptoms of schizophrenia in patients with various profiles of symptoms, cognitive deficits and illness duration. We also aim to investigate the biological and cognitive effects of hf-tRNS and to identify the predictors of clinical response.MethodsIn a randomized, double-blind, 2-arm parallel-group, controlled, multicentre study, 144 patients with schizophrenia and persistent symptoms despite the prescription of at least one antipsychotic treatment will be randomly allocated to receive either active (n = 72) or sham (n = 72) hf-tRNS. hf-tRNS (100–500 Hz) will be delivered for 20 min with a current intensity of 2 mA and a 1-mA offset twice a day on 5 consecutive weekdays. The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left temporoparietal junction. Patients’ symptoms will be assessed prior to hf-tRNS (baseline), after the 10 sessions, and at 1-, 3- and 6-month follow-up. The primary outcome will be the number of responders defined as a reduction of at least 25% from the baseline scores on the Positive and Negative Syndrome Scale (PANSS) after the 10 sessions. Secondary outcomes will include brain activity and connectivity, source monitoring performances, social cognition, other clinical (including auditory hallucinations) and biological variables, and attitude toward treatment.DiscussionThe results of this trial will constitute a first step toward establishing the usefulness of hf-tRNS in schizophrenia whatever the stage of the illness and the level of treatment resistance. We hypothesize a long-lasting effect of active hf-tRNS on the severity of schizophrenia symptoms as compared to sham. This trial will also have implications for the use of hf-tRNS as a preventive intervention of relapse in patients with schizophrenia.Trial registrationClinicalTrials.gov NCT02744989. Prospectively registered on 20 April 2016

【 授权许可】

CC BY