Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870909
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Auditory Hallucinations Procedure: active tDCS Procedure: sham tDCS Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia
Actual Study Start Date : February 2, 2009
Actual Primary Completion Date : April 21, 2016
Actual Study Completion Date : July 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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
Intensity 2 mA during 20 minutes, 2 times per day
Other Names:
  • tDCS
  • transDirect Current Stimulation
  • Anodal tDCS
  • Cathodal 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
sham condition as delivered by the stimulator
Other Name: tDCS placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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:

  • Concomitant major and unstable medical or neurologic illness
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00870909

Hopital Le vinatier
Bron, France, 69677
Laboratoire de Recherche " Vulnérabilité Aux Psychoses "
Monastir, Tunisia
Sponsors and Collaborators
Hôpital le Vinatier
Principal Investigator: emmanuel poulet, MD, PhD Hopital Le Vinatier
Study Director: JEROME BRUNELIN, PhD Hopital le Vinatier

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hôpital le Vinatier Identifier: NCT00870909     History of Changes
Other Study ID Numbers: 2008-A01226-49
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms