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CompletedNCT00870909Updated Mar 1, 2017

Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

An interventional study of active tDCS and sham tDCS in Schizophrenia and Auditory Hallucinations, sponsored by Hôpital le Vinatier. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study summary

The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia.

Read the detailed description

The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.

Using anodal \& cathodal tDCS the investigators aimed to treat auditory hallucinations, a symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 60 patients (30 in each group). 30 patients will be included in a French center (Hospital le Vinatier, sponsor of the study) and 30 in Tunisia (laboratory "vulnerability to psychosis" (Pr Gaha) à Monastir).

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Conditions studied

  • Schizophrenia
  • Auditory Hallucinations
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In context

Hallucinations

132 studies on the registry are indexed under Hallucinations; 36 are open to participants now.

This study's enrollment of 46 is close to the median of 50 across 112 interventional studies indexed under Hallucinations.

Browse Hallucinations studies →

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Schizophrenia according to Diagnostic and Statistical Manual - DSM-IV
  • Auditory verbal hallucinations for at least 6 weeks (despite antipsychotic drugs)
  • Medication Resistance according to Kane et al., 1988
  • Age between 18 and 50 years old
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Concomitant major and unstable medical or neurologic illness
  • Pregnant
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    active tDCS

    tDCS active; - Intensity = 2 milliamps (mA) during 20 minutes. ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC combined with cathodal tDCS applied over the left temporoparietal junction (TPJ). 10 sessions, 2 per day

    Procedure: active tDCS

  • Placebo comparator
    sham tDCS

    tDCS placebo same electrode montage than in the active group. 30 sec of active tDCS in the beginning of the stimulation sessions; ramp up/ramp down 30 sec

    Procedure: sham tDCS

Interventions

  • Procedureactive tDCS

    Intensity 2 mA during 20 minutes, 2 times per day

    Also known as: tDCS, transDirect Current Stimulation, Anodal tDCS, Cathodal tDCS

  • Proceduresham tDCS

    sham condition as delivered by the stimulator

    Also known as: tDCS placebo

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What researchers measure

Primary outcomes

  1. Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)

    Time frame: before, after 1 week of treatment and 2 times follow up (1 & 3 months)

Secondary outcomes

  1. Neurochemical impact of treatment measured by 1H-MRS (proton Magnetic Resonance Spectroscopy), DTI (Diffusion Tensor Imaging) and resting MRI

    Time frame: 3 times: before treatment, immediately after treatment and a last evaluation 1 month after

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Study locations

2 sites
  • Hopital Le vinatier
    Bron, 69677, France
  • Laboratoire de Recherche " Vulnérabilité Aux Psychoses "
    Monastir, Tunisia
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References and documents

Publications

  • Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum In: Am J Psychiatry. 2012 Dec 1;169(12):1321. PubMed 22581236 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00870909
Lead sponsor
Hôpital le Vinatier
Responsible party
Sponsor
First posted
Mar 27, 2009
Start date
Feb 2, 2009
Primary completion
Apr 21, 2016
Completion
Jul 20, 2016
Last update
Mar 1, 2017

Study contacts

emmanuel poulet, MD, PhD
principal investigator · Hopital Le Vinatier
JEROME BRUNELIN, PhD
study director · Hopital le Vinatier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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