Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia

Study Overview
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Brief Summary
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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 effuicacy of tDCS on auditory hallucinations we perfor an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks

Official Title
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Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study

Conditions
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Schizophrenia, Hallucinations, Refractory Schizophrenia

Intervention / Treatment
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* Device: transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transcranial direct current stimulation<br>The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG. | Device: transcranial direct current stimulation<br>* transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic<br>* Other names: tDCS;|
| Sham Comparator: transcranial direct current stimulation sham<br>tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation. | Device: transcranial direct current stimulation<br>* transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 15 days after | 
| CGI | clinical global impression (Kadouri et al. 2007) | At baseline | 
| CGI | clinical global impression (Kadouri et al. 2007) | 15 days after |