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Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

Primary Purpose

Schizophrenia, Auditory Hallucinations

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
active tDCS
sham tDCS
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Le vinatier
  • Laboratoire de Recherche " Vulnérabilité Aux Psychoses "

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active tDCS

sham tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)

Secondary Outcome Measures

Neurochemical impact of treatment measured by 1H-MRS (proton Magnetic Resonance Spectroscopy), DTI (Diffusion Tensor Imaging) and resting MRI

Full Information

First Posted
March 26, 2009
Last Updated
February 28, 2017
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT00870909
Brief Title
Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia
Official Title
Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2009 (Actual)
Primary Completion Date
April 21, 2016 (Actual)
Study Completion Date
July 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Auditory Hallucinations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
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
Arm Title
sham tDCS
Arm Type
Placebo Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
active tDCS
Other Intervention Name(s)
tDCS, transDirect Current Stimulation, Anodal tDCS, Cathodal tDCS
Intervention Description
Intensity 2 mA during 20 minutes, 2 times per day
Intervention Type
Procedure
Intervention Name(s)
sham tDCS
Other Intervention Name(s)
tDCS placebo
Intervention Description
sham condition as delivered by the stimulator
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emmanuel poulet, MD, PhD
Organizational Affiliation
Hopital Le Vinatier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JEROME BRUNELIN, PhD
Organizational Affiliation
Hopital le Vinatier
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Le vinatier
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Laboratoire de Recherche " Vulnérabilité Aux Psychoses "
City
Monastir
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22581236
Citation
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.
Results Reference
derived

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Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

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