Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hôpital le Vinatier
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT00870909
First received: March 26, 2009
Last updated: October 3, 2014
Last verified: October 2014

March 26, 2009
October 3, 2014
January 2009
September 2015   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00870909 on ClinicalTrials.gov Archive Site
Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI [ Time Frame: 3 times, before treatment, immediatly after treatment and a last evaluation 1 month after ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Schizophrenia
  • Auditory Hallucinations
  • Procedure: active tDCS
    Intensity 2 mA during 20 minutes, 2 times per day
    Other Names:
    • tDCS
    • transDirect Current Stimulation
    • Anodal tDCS
    • Cathodal tDCS
  • Procedure: sham tDCS
    sham condition as delivered by the stimulator
    Other Names:
    • sham tDCS
    • tDCS placebo
  • Active Comparator: active tDCS
    tDCS active; - Intensity = 2mA during 20 minutes. ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC combined with cathodal tDCS applied over the left TPJ 10 sessions, 2 per day
    Intervention: Procedure: active tDCS
  • Placebo Comparator: sham tDCS
    tDCS placebo same electrode montage than in the active group. 30 sec of active tDCS in the begining of the stimulation sessions; ramp up/ramp down 30sec
    Intervention: Procedure: sham tDCS
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 1;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum in: Am J Psychiatry. 2012 Dec 1;169(12):1321.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Schizophrenia according to DSM-IV
  • Auditory 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
Both
18 Years to 50 Years
No
France,   Tunisia
 
NCT00870909
2008-A01226-49
No
Hôpital le Vinatier
Hôpital le Vinatier
Not Provided
Principal Investigator: emmanuel poulet, MD, PhD Hopital Le Vinatier
Study Director: JEROME BRUNELIN, PhD Hopital le Vinatier
Hôpital le Vinatier
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP