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Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia (TDCSHALLU)

Primary Purpose

Schizophrenia, Hallucinations, Refractory Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Centre hospitalier de Ville-Evrard, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Schizophrenia according to DSM-V.
  • Refractory auditory hallucinations(despite two antipsychotics trials).
  • Right-handed patients.
  • Written informed consent.

Exclusion Criteria:

  • Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ).
  • History of severe head trauma or coma.
  • History of epilepsy or neurological disorder or a general medical condition.
  • Presence of intracranial metallic objects or pacemaker.
  • Hospitalized patients without consent.
  • pregnant women .

Sites / Locations

  • unité de recherche clinique de l'E.P.S de Ville EvrardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

transcranial direct current stimulation

transcranial direct current stimulation sham

Arm Description

The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG.

tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation.

Outcomes

Primary Outcome Measures

auditory hallucinations rating scale (AHRS)
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).
auditory hallucinations rating scale (AHRS)
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).

Secondary Outcome Measures

PANSS,
Positive and negative symptom scale (PANSS, Kay et al. 1988)
PANSS,
Positive and negative symptom scale (PANSS, Kay et al. 1988)
CGI
clinical global impression (Kadouri et al. 2007)
CGI
clinical global impression (Kadouri et al. 2007)

Full Information

First Posted
October 27, 2015
Last Updated
October 21, 2021
Sponsor
Centre hospitalier de Ville-Evrard, France
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1. Study Identification

Unique Protocol Identification Number
NCT04352569
Brief Title
Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia
Acronym
TDCSHALLU
Official Title
Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2016 (Actual)
Primary Completion Date
May 10, 2016 (Actual)
Study Completion Date
January 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de Ville-Evrard, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
the regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region. to assess the effuicacy of tDCS on auditory hallucinations we perfor an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transcranial direct current stimulation
Arm Type
Active Comparator
Arm Description
The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG.
Arm Title
transcranial direct current stimulation sham
Arm Type
Sham Comparator
Arm Description
tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic
Primary Outcome Measure Information:
Title
auditory hallucinations rating scale (AHRS)
Description
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).
Time Frame
At baseline
Title
auditory hallucinations rating scale (AHRS)
Description
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).
Time Frame
15 days after
Secondary Outcome Measure Information:
Title
PANSS,
Description
Positive and negative symptom scale (PANSS, Kay et al. 1988)
Time Frame
At baseline
Title
PANSS,
Description
Positive and negative symptom scale (PANSS, Kay et al. 1988)
Time Frame
15 days after
Title
CGI
Description
clinical global impression (Kadouri et al. 2007)
Time Frame
At baseline
Title
CGI
Description
clinical global impression (Kadouri et al. 2007)
Time Frame
15 days after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Schizophrenia according to DSM-V. Refractory auditory hallucinations(despite two antipsychotics trials). Right-handed patients. Written informed consent. Exclusion Criteria: Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ). History of severe head trauma or coma. History of epilepsy or neurological disorder or a general medical condition. Presence of intracranial metallic objects or pacemaker. Hospitalized patients without consent. pregnant women .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rusheenthira THAVASEELAN, Msc
Phone
0143093232
Email
r.thavaseelan@epsve.fr
First Name & Middle Initial & Last Name or Official Title & Degree
NOOMANE BOUAZIZ, MD
Phone
0143093232
Email
urcve1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NOOMANE BOUAZIZ, MD
Organizational Affiliation
Unité de Recherche Clinique de l'EPS de Ville Evard
Official's Role
Principal Investigator
Facility Information:
Facility Name
unité de recherche clinique de l'E.P.S de Ville Evrard
City
Neuilly Sur Marne
ZIP/Postal Code
93332
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rusheenthira THAVASEELAN, Msc
Phone
0143093232
Email
r.thavaseelan@epsve.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia

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