Clinical trial NCT00870909: Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia
Official title: Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Auditory Hallucinations
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)
timeFrame: before, after 1 week of treatment and 2 times follow up (1 & 3 months)
Secondary outcomes:
measure: Neurochemical impact of treatment measured by 1H-MRS (proton Magnetic Resonance Spectroscopy), DTI (Diffusion Tensor Imaging) and resting MRI
timeFrame: 3 times: before treatment, immediately after treatment and a last evaluation 1 month after
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Le vinatier
city: Monastir
country: Tunisia
facility: Laboratoire de Recherche " Vulnérabilité Aux Psychoses "
Study officials:
affiliation: Hopital Le Vinatier
name: emmanuel poulet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital le Vinatier
name: JEROME BRUNELIN, PhD
role: STUDY_DIRECTOR
References:
citation: 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.