We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870909
First Posted: March 27, 2009
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hôpital le Vinatier
March 26, 2009
March 27, 2009
March 1, 2017
February 2, 2009
April 21, 2016   (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) ]
Same as current
Complete list of historical versions of study NCT00870909 on ClinicalTrials.gov Archive Site
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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Name: tDCS placebo
  • 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

    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 beginning of the stimulation sessions; ramp up/ramp down 30 sec
    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;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.
 
Completed
46
July 20, 2016
April 21, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Tunisia
 
 
NCT00870909
2008-A01226-49
No
Not Provided
Not Provided
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
February 2017

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