Clinical trial NCT04352569: Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia
Official title: Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Hallucinations
Refractory Schizophrenia
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

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 .

Primary outcomes:
measure: auditory hallucinations rating scale (AHRS)
timeFrame: At baseline
measure: auditory hallucinations rating scale (AHRS)
timeFrame: 15 days after
Secondary outcomes:
measure: PANSS,
timeFrame: At baseline
measure: PANSS,
timeFrame: 15 days after
measure: CGI
timeFrame: At baseline
measure: CGI
timeFrame: 15 days after
Other outcomes:
Locations:
city: Neuilly Sur Marne
country: France
facility: unité de recherche clinique de l'E.P.S de Ville Evrard
Study officials:
affiliation: Unité de Recherche Clinique de l'EPS de Ville Evard
name: NOOMANE BOUAZIZ, MD
role: PRINCIPAL_INVESTIGATOR
References: