Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

February 28, 2017 updated by: Hôpital le Vinatier

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hopital Le Vinatier
  • Tunisia
      • Monastir, Tunisia
        • Laboratoire de Recherche " Vulnérabilité Aux Psychoses "

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Procedure: active tDCS
Intensity 2 mA during 20 minutes, 2 times per day
Other Names:
  • tDCS
  • Anodal tDCS
  • transDirect Current Stimulation
  • Cathodal tDCS
Placebo Comparator: 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
Procedure: sham tDCS
sham condition as delivered by the stimulator
Other Names:
  • tDCS placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2009

Primary Completion (Actual)

April 21, 2016

Study Completion (Actual)

July 20, 2016

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-A01226-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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