tDCS & Auditory Hallucinations in Schizophrenia

Study Overview
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Brief Summary
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The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.

Official Title
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tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: Active tDCS
* Device: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-60 Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia Persistent auditory verbal hallucinations Right handed Under stable doses of antipsychotic medication for ≥4 weeks Normal hearing by self-report and physical exam Use of effective method of birth control for women of childbearing capacity Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent Exclusion Criteria: Current or past history of substance dependence or abuse (excluding nicotine) Other current Axis I disorders History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator) Frequent and persistent migraines History of adverse reaction to neurostimulation Participation in study of investigational medication within 6 weeks Pregnancy Women who are breast-feeding Current significant laboratory abnormality

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Active tDCS<br>active tDCS | Device: Active tDCS<br>* repetitive daily tDCS sessions for a period of one week<br>|
| Sham Comparator: control<br>sham (placebo) tDCS condition | Device: control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in auditory hallucination rating scale |  | 1 week post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in self-report quality of life scale from baseline |  | 1 week post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation (tDCS), dorsolateral prefrontal cortex, left superior temporal gyrus, auditory hallucinations