NCT04352569

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 efficacy of tDCS on auditory hallucinations, the investigators performs an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 3, 2016

Completed
4 years until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

7.6 years

First QC Date

October 27, 2015

Last Update Submit

February 15, 2024

Conditions

SchizophreniaHallucinationsRefractory Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • auditory hallucinations rating scale (AHRS)

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

    At baseline

  • auditory hallucinations rating scale (AHRS)

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

    15 days after

Secondary Outcomes (4)

  • PANSS,

    At baseline

  • PANSS,

    15 days after

  • CGI

    At baseline

  • CGI

    15 days after

Study Arms (2)

transcranial direct current stimulation

ACTIVE COMPARATOR

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

Device: transcranial direct current stimulation

transcranial direct current stimulation sham

SHAM COMPARATOR

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

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulationDEVICE

transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic

Also known as: tDCS
transcranial direct current stimulationtranscranial direct current stimulation sham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

unité de recherche clinique de l'E.P.S de Ville Evrard

Neuilly-sur-Marne, 93332, France

RECRUITING

MeSH Terms

Conditions

SchizophreniaHallucinationsSchizophrenia, Treatment-Resistant

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

  • NOOMANE BOUAZIZ, MD

    Unité de Recherche Clinique de l'EPS de Ville Evard

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rusheenthira THAVASEELAN, Msc

CONTACT

0143093232r.thavaseelan@epsve.fr

NOOMANE BOUAZIZ, MD

CONTACT

0143093232urcve1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 27, 2015

First Posted

April 20, 2020

Study Start

May 3, 2016

Primary Completion

December 8, 2023

Study Completion

March 10, 2026

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

FR(1)