Hallucinations, Refractory Schizophrenia, Schizophrenia
Conditions
Brief summary
The regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region. To assess the efficacy of tDCS on auditory hallucinations, the investigators performs an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks.
Detailed description
Hearing hallucinations are one of the major symptoms of schizophrenia. In 30% of patients they are resistant to common psychotropic treatments. tDCS (Transcranial Direct Current Stimulation) is a technical of brain stimulation, non-invasive, painless that modulates brain activity by the transcranial administration of a low-intensity electric current, via two electrodes (an anode and a cathode). Several scientifics studies have reported a beneficial effect of tDCS in the treatment of pain, depression and especially hearing hallucinations in schizophrenia. The main study purpose is to evaluate the effectiveness of tDCS on resistant auditory hallucinations in patients with schizophrenia. Then, to evaluate the effectiveness of tDCS on global schizophrenic symptomatology and to assess the impact of tDCS on patients' quality of life. Also the study, evaluate the impact of tDCS on cortical excitability. We measure the change in serum BDNF (Brain Derived Neutrophic Factor) before and after tDCS stimulation. Indeed, to evaluate the impact of tDCS on neurocognitive functions. Patients will receive either active tDCS or placebo tDCS randomly. All patients will have two tDCS/day sessions, one hour apart, for 2 working weeks. The stimulation parameters will be consistent with the literature data, namely: Intensity = 2mA; duration of sessions = 20 minutes; total number of sessions = 20 (2 daily sessions for two working weeks).
Interventions
DEVICEtranscranial direct current stimulation
transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic
Sponsors
Centre hospitalier de Ville-Evrard, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Schizophrenia according to DSM-V. * Refractory auditory hallucinations(despite two antipsychotics trials). * Right-handed patients. * Written informed consent.
Exclusion criteria
* Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ). * History of severe head trauma or coma. * History of epilepsy or neurological disorder or a general medical condition. * Presence of intracranial metallic objects or pacemaker. * Hospitalized patients without consent. * pregnant women .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| auditory hallucinations rating scale (AHRS) | At baseline | AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PANSS, | At baseline | Positive and negative symptom scale (PANSS, Kay et al. 1988) |
| CGI | At baseline | clinical global impression (Kadouri et al. 2007) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNOOMANE BOUAZIZ, MD
Unité de Recherche Clinique de l'EPS de Ville Evard
Outcome results
None listed