STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia
Condition: Mental Disorders; Schizophrenia
MeSH terms: Schizophrenia; Mental Disorders
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Neuroconn or Neuroelectric tDCS stimulator; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Stimulation parameters were chosen in conformity with those for the treatment of schizophrenic symptoms (Brunelin et al, 2012), adapted according to the latest data from the literature and the tDCS operating stimulator. The experimental tDCS group will receive the ACTIVE stimulation with the following parameters: oscillatory Direct Current with high frequency random noise stimulation (hf-tRNS - 100 to 500 Hz), Intensity = 2 mA, offset = + 1 mA, seance duration = 20 minutes ramp up/ramp down 30 seconds. Total number of sessions = 10 (sessions twice daily for 5 days separated by at least 2 hours for 5 consecutive weekdays).; The control group will receive the SHAM stimulation (placebo) following the same regimen (i.e., twice daily sessions separated by at least 2 hours for 5 consecutive weekdays). Sham stimulation consists of a 20 minutes session including 40 seconds of active stimulation (same parameters as in the ACTIVE arm) at the beginning of the sessions, whatever the stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Schizophrenia; Transcranial direct-current stimulation (tDCS); Sham; Positive and Negative Syndrome Scale (PANSS); Functional Magnetic Resonance Imaging (fRMI); Brain-Derived-Neurotrophic Factor (BDNF)