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Completed

NCT Number: NCT00870909

Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Le vinatier, Bron, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

  • Concomitant major and unstable medical or neurologic illness
  • Pregnant

Treatment and study plan

Active tDCS

Procedure

Intensity 2 mA during 20 minutes, 2 times per day

Other names: tDCS, transDirect Current Stimulation, Anodal tDCS, Cathodal tDCS

Sham tDCS

Procedure

sham condition as delivered by the stimulator

Other names: tDCS placebo

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

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Mar 27, 2009
Registry last updated
Mar 1, 2017

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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