Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 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: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Schizophrenia
Auditory Hallucinations
Procedure: direct current stimulation over brain areas
Procedure: direct current stimulation (sham)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Hôpital le Vinatier:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: November 2015
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active tDCS
tDCS active; - Intensity = 2mA during 20 minutes. 10 sessions, 2 per day
Procedure: direct current stimulation over brain areas
Intensity 2 mA during 20 minutes, 2 times per day
Other Names:
  • tDCS
  • transDirect Current Stimulation
  • Anodal tDCS
  • Cathodal tDCS
Placebo Comparator: tDCS placebo
tDCS placebo
Procedure: direct current stimulation (sham)
sham condition as delivered by the stimulator
Other Names:
  • sham tDCS
  • tDCS placebo

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870909

Locations
France
Hopital Le vinatier Recruiting
Bron, France, 69677
Contact: emmanuel poulet, MD, PhD    33437915100      
Principal Investigator: emmanuel poulet, md, phd         
Tunisia
Laboratoire de Recherche " Vulnérabilité Aux Psychoses " Recruiting
Monastir, Tunisia
Contact: anwar mechri, md, PhD    (00216) 73 462 200    anwar_mec@yahoo.fr   
Sub-Investigator: lofti gaha, MD, PhD         
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Principal Investigator: emmanuel poulet, MD, PhD Hopital Le Vinatier
Study Director: JEROME BRUNELIN, PhD Hopital le Vinatier
  More Information

No publications provided by Hôpital le Vinatier

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT00870909     History of Changes
Other Study ID Numbers: 2008-A01226-49
Study First Received: March 26, 2009
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Tunisia: Ministry of Public Health

Additional relevant MeSH terms:
Hallucinations
Schizophrenia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014