Title {1} | 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 |
Trial registration {2a and 2b}. | Clinicaltrials.gov registration number: NCT 02744989, first posted on April 20, 2016 |
Protocol version {3} | version 13 on July 13th, 2021, substantial modification n°10 |
Funding {4} | The French Ministry of health, DGOS, PHRC 14-0042 (2014) |
Author details {5a} |
1. Centre Hospitalier Le Vinatier, PSYR2 team, Bat 416 – 1st floor; 95 boulevard Pinel, 69678, F-69500, Bron cedex, France 2. INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, F-69000, Lyon, France 3. Lyon 1 University, F-69000, Villeurbanne, France 4. Université Jean Monnet Saint Etienne, F-42000, Saint Etienne, France 5. Hospices Civils de Lyon, Pôle Santé Publique, Service Recherche et Epidémiologie Cliniques, F-69003, Lyon, France 6. Research on Healthcare Performance RESHAPE, INSERM U1290, Université Claude Bernard Lyon 1, Villeurbanne, France 7. CHU Montpellier, F-34295, Montpellier, France 8. CHU Nice, F-06001, Nice, France 9. Paris Brain Institute – Institut du Cerveau (ICM), Inserm U 1127, CNRS UMR 7225, Sorbonne Université, F-75013, Paris,France 10. CATI Multicenter Neuroimaging Platform, F-75000, Paris, France 11. CHU Caen, F-14033, Caen, France 12. CHRU de Tours, CIC 1415, INSERM, Tours; UMR 1253, iBrain, Université de Tours, INSERM, F-37044, Tours, France 13. University in Lille, INSERM U1172, CHU Lille, Lille Neuroscience & Cognition Research Centre, Plasticity & SubjectivitY(PSY) team, CURE Platform, Lille, France 14. CHU de Clermont-Ferrand, F-63003, Clermont-Ferrand, France 15. GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, F-75014, Paris, France 16. Université de Paris, F-75005, Paris, France 17. CH Princess Grace, MC-98000, Monaco, Monaco 18. CHU de Saint Etienne, F-42000, Saint Etienne, France 19. Psychiatric emergency service, Hospices civils de Lyon, F-69005, Lyon, France |
Name and contact information for the trial sponsor {5b} |
Aleandre PACHOT, Deputy Director of Clinical Research and Innovation Hospices Civils de Lyon, Direction de la Recherche Clinique et de l’Innovation, Siège Administratif, BP 2251, 3 Quai des Célestins, 69229 LYON Cedex 02 Tél : 0033 472 406 852, Fax : 0033 472 406 869 Alexandre.pachot@chu-lyon.fr |
Role of sponsor {5c} |
The study sponsor had no role in the design of this study and no any role during its execution, analyses, interpretation of the data, or decision to submit results. The funder of the study had no role in study design, data collection, data interpretation, or writing of the report. |