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

Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Hallucinations; Refractory Schizophrenia
• Intervention / Treatment: Device: transcranial direct current stimulation

Detailed Description

Hearing hallucinations are one of the major symptoms of schizophrenia. In 30% of patients they are resistant to common psychotropic treatments. tDCS (Transcranial Direct Current Stimulation) is a technical of brain stimulation, non-invasive, painless that modulates brain activity by the transcranial administration of a low-intensity electric current, via two electrodes (an anode and a cathode). Several scientifics studies have reported a beneficial effect of tDCS in the treatment of pain, depression and especially hearing hallucinations in schizophrenia.

The main study purpose is to evaluate the effectiveness of tDCS on resistant auditory hallucinations in patients with schizophrenia.

Then, to evaluate the effectiveness of tDCS on global schizophrenic symptomatology and to assess the impact of tDCS on patients' quality of life.

Also the study, evaluate the impact of tDCS on cortical excitability. We measure the change in serum BDNF (Brain Derived Neutrophic Factor) before and after tDCS stimulation. Indeed, to evaluate the impact of tDCS on neurocognitive functions.

Patients will receive either active tDCS or placebo tDCS randomly. All patients will have two tDCS/day sessions, one hour apart, for 2 working weeks. The stimulation parameters will be consistent with the literature data, namely: Intensity = 2mA; duration of sessions = 20 minutes; total number of sessions = 20 (2 daily sessions for two working weeks).

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rusheenthira THAVASEELAN, Msc; Phone Number: 0143093232; Email: r.thavaseelan@epsve.fr
• Study Contact Backup: Name: NOOMANE BOUAZIZ, MD; Phone Number: 0143093232; Email: urcve1@gmail.com

Study Locations

• France
  • Neuilly Sur Marne, France, 93332
    • Recruiting
    • unité de recherche clinique de l'E.P.S de Ville Evrard
    • Contact: Rusheenthira THAVASEELAN, Msc; Phone Number: 0143093232; Email: r.thavaseelan@epsve.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: transcranial direct current stimulation; 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 (tDCS) is a non invasive brain stimulation technic; Other Names: tDCS
Sham Comparator: transcranial direct current stimulation sham; tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation.	Device: transcranial direct current stimulation; transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic; Other Names: tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PANSS,	Positive and negative symptom scale (PANSS, Kay et al. 1988)	At baseline
PANSS,	Positive and negative symptom scale (PANSS, Kay et al. 1988)	15 days after
CGI	clinical global impression (Kadouri et al. 2007)	At baseline
CGI	clinical global impression (Kadouri et al. 2007)	15 days after

Collaborators and Investigators

• Sponsor: Centre hospitalier de Ville-Evrard, France
• Investigators: Principal Investigator: NOOMANE BOUAZIZ, MD, Unité de Recherche Clinique de l'EPS de Ville Evard

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2016
• Primary Completion (Actual): December 8, 2023
• Study Completion (Estimated): March 10, 2026

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Schizophrenia; Hallucinations; Schizophrenia, Treatment-Resistant
• Other Study ID Numbers: DMDPT-TCH/MM/2015-A00842-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED