Clinical trial NCT06599372: Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia
Official title: Treatment of Resistant Auditory Hallucinations in Schizophrenia by Repetitive Transcranial Magnetic Stimulation. Naturalistic Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Transcranial Magnetic Stimulation
Hallucinations, Verbal Auditory
Keywords: hallucinations
resistant auditory hallucinations
schizophrenia
TMS
Transcranial magnetic stimulation
TBS
Theta burst stimulation
a improvement
real-life conditions
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS scale to evaluate the effectiveness of rTMS on RAH in patients with schizophrenia. Our main hypothesis is that rTMS used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the AHRS scale between baseline and end of treatment in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Patient diagnosed with schizophrenia according to DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
* Presence of auditory hallucinations: Resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics.
* Patient agreeing to participate in the study and having signed an informed consent
* Patient with French language skills
* Affiliation to a social security system
* Women of childbearing age must be on contraception and have a negative pregnancy test (βHCG)

Exclusion Criteria:

* Have a contraindication to MST: intracranial foreign body, unstabilized epilepsy, cochlear implant
* Presence of an unstabilized medical condition
* Pregnant woman (Women of childbearing age without effective contraception)
* Current or less than one month old engagement in another research protocol
* A person who is subject to a safeguard of justice measure
* An adult under curatorship
* Minor patients with mental health problems
* Pregnant or breastfeeding women
* A person in a social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons)
* Persons incapable or unable to give consent

Primary outcomes:
measure: The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)
timeFrame: Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment
Secondary outcomes:
measure: Response rate: a response is defined as a decrease greater than or equal to 30% of total AHRS score from baseline to end of treatment.
timeFrame: Baseline and at the end of the treatment
measure: Rate of patients with an end-of-treatment score < 3 on the Positive And Negative Syndrome Scale (PANSS) "Hallucinatory Behavior" item
timeFrame: Baseline and at the end of the treatment
measure: Cognitive symptoms: Montreal Cognitive Assessment (MOCA), Stroop
timeFrame: Baseline and 1 month after the end of treatment
measure: Addictive attitudes: number of cigarettes/d (tobacco), The Cannabis Abuse Screening Test (CAST), Marijuana Craving Questionnaire (MCQ)
timeFrame: Baseline and at the end of the treatment
measure: Mood: Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Baseline and the end of the treatment
measure: Quality of life: The Subjective Quality of Life Scale (S-QoL)
timeFrame: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment
measure: Clinical Global Impressions (CGI) Scale
timeFrame: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment
Other outcomes:
Locations:
city: Neuilly-sur-Marne
country: France
facility: Etablissement Public de Santé de Ville-Evrard
Study officials:
affiliation: Clinical research unit, EPS Ville Evrard
name: Dominique JANUEL
role: STUDY_DIRECTOR
affiliation: Clinical research unit, EPS Ville Evrard
name: Noomane BOUAZIZ
role: PRINCIPAL_INVESTIGATOR
References: