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Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

H

Hôpital le Vinatier

Status

Completed

Conditions

Auditory Hallucinations
Schizophrenia

Treatments

Procedure: sham tDCS
Procedure: active tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT00870909
2008-A01226-49

Details and patient eligibility

About

The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia.

Full 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).

Enrollment

46 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups, including a placebo group

active tDCS
Active Comparator group
Description:
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
Treatment:
Procedure: active tDCS
sham tDCS
Placebo Comparator group
Description:
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
Treatment:
Procedure: sham tDCS

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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