NCT00870909

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable schizophrenia

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2016

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

7.2 years

First QC Date

March 26, 2009

Last Update Submit

February 28, 2017

Conditions

SchizophreniaAuditory Hallucinations

Outcome Measures

Primary Outcomes (1)

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

    before, after 1 week of treatment and 2 times follow up (1 & 3 months)

Secondary Outcomes (1)

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

    3 times: before treatment, immediately after treatment and a last evaluation 1 month after

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

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

sham tDCS

PLACEBO COMPARATOR

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

Interventions

active tDCSPROCEDURE

Intensity 2 mA during 20 minutes, 2 times per day

Also known as: tDCS, transDirect Current Stimulation, Anodal tDCS, Cathodal tDCS
active tDCS
sham tDCSPROCEDURE

sham condition as delivered by the stimulator

Also known as: tDCS placebo
sham tDCS

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Concomitant major and unstable medical or neurologic illness
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Le vinatier

Bron, 69677, France

Location

Laboratoire de Recherche " Vulnérabilité Aux Psychoses "

Monastir, Tunisia

Location

Related Publications (1)

  • 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.

    PMID: 22581236DERIVED

MeSH Terms

Conditions

SchizophreniaHallucinations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • emmanuel poulet, MD, PhD

    Hopital Le Vinatier

    PRINCIPAL INVESTIGATOR

  • JEROME BRUNELIN, PhD

    Hopital le Vinatier

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

February 2, 2009

Primary Completion

April 21, 2016

Study Completion

July 20, 2016

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

TU(1)FR(1)