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CompletedNCT04352569TDCSHALLUUpdated Aug 6, 2026

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

An interventional study of transcranial direct current stimulation in Schizophrenia, Hallucinations and Refractory Schizophrenia, sponsored by Centre hospitalier de Ville-Evrard, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.

Primary conditionSchizophrenia, Treatment-ResistantRegistry: SchizophreniaReclassifiedWhy we changed it
Registry
Schizophrenia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Schizophrenia, Treatment-Resistant
Why
  1. The study's listed conditions name Schizophrenia, Treatment-Resistant, a narrower term within Schizophrenia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Centre hospitalier de Ville-Evrard, France · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Schizophrenia
  • Hallucinations
  • Refractory Schizophrenia

Browse trials for

03

In context

Schizophrenia, Treatment-Resistant Reclassified

53 studies on the registry are indexed under Schizophrenia, Treatment-Resistant; 22 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 46 interventional studies indexed under Schizophrenia, Treatment-Resistant.

Browse Schizophrenia, Treatment-Resistant studies →

Lead sponsor

Centre hospitalier de Ville-Evrard, France is the lead sponsor of 22 studies on the registry; 14 are open to participants now.

Compared within Schizophrenia, Treatment-Resistant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Schizophrenia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Schizophrenia according to .
  • auditory hallucinations(despite two antipsychotics trials).
  • Right-handed patients.
  • Written .

Exclusion criteria

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 .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    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.

    Device: transcranial direct current stimulation

  • Sham comparator
    transcranial direct current stimulation sham

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

    Device: transcranial direct current stimulation

Interventions

  • Devicetranscranial direct current stimulation

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

    Also known as: tDCS

06

What researchers measure

Primary outcomes

  1. auditory hallucinations rating scale (AHRS)

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

    Time frame: At baseline

  2. auditory hallucinations rating scale (AHRS)

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

    Time frame: 15 days after

Secondary outcomes

  1. PANSS,

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

    Time frame: At baseline

  2. PANSS,

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

    Time frame: 15 days after

  3. CGI

    clinical global impression (Kadouri et al. 2007)

    Time frame: At baseline

  4. CGI

    clinical global impression (Kadouri et al. 2007)

    Time frame: 15 days after

07

Study locations

1 site
  • unité de recherche clinique de l'E.P.S de Ville Evrard
    Neuilly-sur-Marne, 93332, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2016 to primary completion in Mar 2025, 106 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2015
First posted
Apr 20, 2020
StartActual
May 3, 2016
Primary completionActual
Mar 31, 2025
CompletionActual
Mar 31, 2025
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04352569
Lead sponsor
Centre hospitalier de Ville-Evrard, France
Responsible party
Noomane Bouaziz, MD (MD, Centre hospitalier de Ville-Evrard, France) — Principal investigator
First posted
Apr 20, 2020
Start date
May 3, 2016
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Last update
Aug 6, 2026

Study contacts

NOOMANE BOUAZIZ, MD
principal investigator · Unité de Recherche Clinique de l'EPS de Ville Evard

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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