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NCT Number: NCT04352569

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

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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Key information

Conditions

Schizophrenia Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Refractory Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

unité de recherche clinique de l'E.P.S de Ville Evrard

Neuilly-sur-Marne, 93332, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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

Other names: tDCS

Primary outcomes

  1. auditory hallucinations rating scale (AHRS)

    Time frame: At baseline

    AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).

  2. auditory hallucinations rating scale (AHRS)

    Time frame: 15 days after

    AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).

Secondary outcomes

  1. PANSS,

    Time frame: At baseline

    Positive and negative symptom scale (PANSS, Kay et al. 1988)

  2. PANSS,

    Time frame: 15 days after

    Positive and negative symptom scale (PANSS, Kay et al. 1988)

  3. CGI

    Time frame: At baseline

    clinical global impression (Kadouri et al. 2007)

  4. CGI

    Time frame: 15 days after

    clinical global impression (Kadouri et al. 2007)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de Ville-Evrard, France

Other

Registry information

Official study title

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

Acronym: TDCSHALLU

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2020
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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