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Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by Hôpital le Vinatier.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Hôpital le Vinatier Identifier:
First received: March 26, 2009
Last updated: October 3, 2014
Last verified: October 2014
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 Intervention
Auditory Hallucinations
Procedure: active tDCS
Procedure: sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia

Resource links provided by NLM:

Further study details as provided by Hôpital le Vinatier:

Primary Outcome Measures:
  • 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:
  • Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI [ Time Frame: 3 times, before treatment, immediatly after treatment and a last evaluation 1 month after ]

Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active tDCS
tDCS active; - Intensity = 2mA during 20 minutes. ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC combined with cathodal tDCS applied over the left 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 begining of the stimulation sessions; ramp up/ramp down 30sec
Procedure: sham tDCS
sham condition as delivered by the stimulator
Other Name: tDCS placebo

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).


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Schizophrenia according to DSM-IV
  • Auditory 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00870909

Hopital Le vinatier Recruiting
Bron, France, 69677
Contact: emmanuel poulet, MD, PhD    33437915100      
Principal Investigator: emmanuel poulet, md, phd         
Laboratoire de Recherche " Vulnérabilité Aux Psychoses " Recruiting
Monastir, Tunisia
Contact: anwar mechri, md, PhD    (00216) 73 462 200   
Sub-Investigator: lofti gaha, MD, PhD         
Sponsors and Collaborators
Hôpital le Vinatier
Principal Investigator: emmanuel poulet, MD, PhD Hopital Le Vinatier
Study Director: JEROME BRUNELIN, PhD Hopital le Vinatier
  More Information

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 
Study First Received: March 26, 2009
Last Updated: October 3, 2014

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on February 24, 2017