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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcranial direct current stimulation | Active Comparator | The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG. |
|
| transcranial direct current stimulation sham | Sham Comparator | tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic |
|
| Measure | Description | Time Frame |
|---|---|---|
| auditory hallucinations rating scale (AHRS) | AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005). | At baseline |
| auditory hallucinations rating scale (AHRS) | AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005). | 15 days after |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS, | Positive and negative symptom scale (PANSS, Kay et al. 1988) | At baseline |
| PANSS, | Positive and negative symptom scale (PANSS, Kay et al. 1988) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rusheenthira THAVASEELAN, Msc | Contact | 0143093232 | r.thavaseelan@epsve.fr | |
| NOOMANE BOUAZIZ, MD | Contact | 0143093232 | urcve1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| NOOMANE BOUAZIZ, MD | Unité de Recherche Clinique de l'EPS de Ville Evard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| unité de recherche clinique de l'E.P.S de Ville Evrard | Recruiting | Neuilly-sur-Marne | 93332 | France |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D006212 | Hallucinations |
| D000090663 | Schizophrenia, Treatment-Resistant |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| 15 days after |
| CGI | clinical global impression (Kadouri et al. 2007) | At baseline |
| CGI | clinical global impression (Kadouri et al. 2007) | 15 days after |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |