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

Schizophrenia Clinical Trial

— TDCSHALLU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04352569
• Other study ID #: DMDPT-TCH/MM/2015-A00842-47
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2016
• Est. completion date: March 10, 2026

Study information

• Verified date: February 2024
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Rusheenthira THAVASEELAN, Msc
• Phone: 0143093232
• Email: r.thavaseelan[@]epsve.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 10, 2026
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Hallucinations
• Refractory Schizophrenia
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
France	unité de recherche clinique de l'E.P.S de Ville Evrard	Neuilly Sur Marne

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	auditory hallucinations rating scale (AHRS)	AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).	At baseline
Primary	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	PANSS,	Positive and negative symptom scale (PANSS, Kay et al. 1988)	At baseline
Secondary	PANSS,	Positive and negative symptom scale (PANSS, Kay et al. 1988)	15 days after
Secondary	CGI	clinical global impression (Kadouri et al. 2007)	At baseline
Secondary	CGI	clinical global impression (Kadouri et al. 2007)	15 days after