Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

NCT ID: NCT00870909

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-02

Study Completion Date

2016-07-20

Brief Summary

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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

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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).

Conditions

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Schizophrenia Auditory Hallucinations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

active tDCS

Intervention Type PROCEDURE

Intensity 2 mA during 20 minutes, 2 times per day

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

Group Type PLACEBO_COMPARATOR

sham tDCS

Intervention Type PROCEDURE

sham condition as delivered by the stimulator

Interventions

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active tDCS

Intensity 2 mA during 20 minutes, 2 times per day

Intervention Type PROCEDURE

sham tDCS

sham condition as delivered by the stimulator

Intervention Type PROCEDURE

Other Intervention Names

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tDCS transDirect Current Stimulation Anodal tDCS Cathodal tDCS tDCS placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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emmanuel poulet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Le Vinatier

JEROME BRUNELIN, PhD

Role: STUDY_DIRECTOR

Hopital le Vinatier

Locations

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Hopital Le vinatier

Bron, , France

Site Status

Laboratoire de Recherche " Vulnérabilité Aux Psychoses "

Monastir, , Tunisia

Site Status

Countries

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France Tunisia

References

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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.

Reference Type DERIVED
PMID: 22581236 (View on PubMed)

Other Identifiers

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2008-A01226-49

Identifier Type: -

Identifier Source: org_study_id

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