Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia; Auditory Hallucinations
• Interventions: Procedure: active tDCS; Procedure: sham tDCS

• Registration Number: NCT00870909
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-02-02
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2016-04-21
• Study Completion: 2016-07-20
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active tDCS	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
sham tDCS	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

Primary Outcome Measures

Name	Time	Method
Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)	before, after 1 week of treatment and 2 times follow up (1 & 3 months)

Secondary Outcome Measures

Name	Time	Method
Neurochemical impact of treatment measured by 1H-MRS (proton Magnetic Resonance Spectroscopy), DTI (Diffusion Tensor Imaging) and resting MRI	3 times: before treatment, immediately after treatment and a last evaluation 1 month after

Trial Locations

Locations (2)

Hopital Le vinatier; 🇫🇷 Bron, France

Laboratoire de Recherche " Vulnérabilité Aux Psychoses "; 🇹🇳 Monastir, Tunisia