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STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia (SCH)
This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication. An early optimization of the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic medication, and will be used in a broad variety of patients, i.e. in patients with varied durations of illness, various symptoms profiles, and various levels of treatment response. This in turn will allow the determination of the extent to which results can be generalized to varied patient populations, as well as the extent to which various therapeutic targets (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS. Despite interesting preliminary results, our team is unable to describe optimal non-invasive brain stimulation (NIBS) response markers. This study is a randomized, double blind, controlled, French multicenter study (11 centers). The investigators plan to include 144 patients with persistent symptoms in schizophrenia. Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders, defined as a decrease of at least 25% of symptoms as measured by a standardized clinical scale score (PANSS) between baseline and after the 10-session tDCS regimen. Furthermore, the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers. An analysis of the effects on cortical activity and plasticity markers could be an interesting approach.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Centre Hospitalier Le Vinatier - Service de Psychiatrie Adulte
Bron, France
Centre Esquirol - CHU de Caen - Service de Psychiatrie Adulte,
Caen, France
CHU de Clermont-Ferrand - Pôle de Psychiatrie B
Clermont-Ferrand, France
Hôpital Fontan - CHRU de Lille - Pôle de Psychiatrie
Lille, France
Hôpital Edouard Herriot - Service d'Urgences Psychiatriques
Lyon, France
Hôpital de la Colombière - CHU Montpellier - Service de Psychiatrie Adulte
Montpellier, France
Centre Hospitalier Saint-Anne - Service de Psychiatrie Adultes
Paris, France
CHU de St-Etienne - Service d'Urgences Psychiatriques
Saint-Etienne, France
CHRU de Tours - Clinique Psychiatrique Universitaire
Tours, France
Centre Hospitalier Princesse Grace - Service de Psychiatrie
Monaco, Monaco
Start Date
May 30, 2016
Primary Completion Date
May 1, 2022
Completion Date
October 19, 2022
Last Updated
December 19, 2025
141
ACTUAL participants
Neuroconn or Neuroelectric tDCS stimulator
DEVICE
Sham tDCS
DEVICE
Lead Sponsor
Hospices Civils de Lyon
NCT06580860
NCT07455929
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06740383