Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870909
• Other study ID #: 2008-A01226-49
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: February 28, 2017
• Start date: February 2, 2009
• Est. completion date: July 20, 2016

Study information

• Verified date: February 2017
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 20, 2016
• Est. primary completion date: April 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Hallucinations
• Hallucinations
• Schizophrenia

Intervention

Procedure:
• active tDCS
Intensity 2 mA during 20 minutes, 2 times per day
• sham tDCS
sham condition as delivered by the stimulator

Locations

Country	Name	City	State
France	Hopital Le vinatier	Bron
Tunisia	Laboratoire de Recherche " Vulnérabilité Aux Psychoses "	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Countries where clinical trial is conducted

France,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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