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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-03

Study Completion Date

2026-03-10

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 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.

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Detailed Description

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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).

Conditions

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Schizophrenia Hallucinations Refractory Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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transcranial direct current stimulation

The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG.

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic

transcranial direct current stimulation sham

tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation.

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic

Interventions

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transcranial direct current stimulation

transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic

Intervention Type DEVICE

Other Intervention Names

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tDCS

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 .

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No