Clinical trial NCT06595654: Treatment of Negative Symptoms of Schizophrenia by rTMS
Official title: Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Negative Symptoms in Schizophrenia
Keywords: rTMS
TMS
Transcranial magnetic stimulation
naturalistic
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
* Stable drug treatment for at least 4 weeks
* Presence or persistence of negative symptoms in the foreground:

Negative PANSS score ⩾21, positive PANSS score ⩽24

* Patient (or legal representative) willing to participate in the study and having signed an informed consent
* Patient fluent in the French language
* Affiliation to a social security scheme

Exclusion Criteria:

* Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
* Presence of an unstabilized medical condition
* Pregnant woman
* Woman of childbearing potential and without effective contraception
* Breastfeeding woman

Primary outcomes:
measure: Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).
timeFrame: Baseline (day 1) to end of treatment (2 or 4 weeks)
Secondary outcomes:
measure: Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI.
timeFrame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.
measure: Assess the impact of this treatment on response rate by the SANS
timeFrame: Baseline (day 1) to end of treatment (2 or 4 weeks)
measure: Assess the impact of this treatment on the rate of remission by the number of remission with the SANS
timeFrame: Baseline (day 1) to end of treatment (2 or 4 weeks)
measure: Assess the impact of this treatment on the relapse rate by the number of relapse with SANS
timeFrame: 4 weeks, 12 weeks and 24 weeks after the end of treatment.
measure: Assess the impact of this treatment on cognitive symptoms by MOCA (Montreal Cognitive Assessment) and STROOP
timeFrame: Baseline (day 1) to end of treatment (2 or 4 weeks)
measure: Assess the impact of this treatment on addictive attitudes by MCQ (Marijuana Craving Questionnaire) and CAST (Cannabis Abuse Screening Test)
timeFrame: Baseline (day 1) to end of treatment (2 or 4 weeks)
measure: Assess the impact of this treatment on mood by CDSS (Calgary Depression Scale for Schizophrenia).
timeFrame: Baseline (day 1) to end of treatment (2 or 4 weeks)
measure: Assess the impact of this treatment on quality of life by S-QoL-18
timeFrame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.
measure: Assess the impact of this treatment on adverse reactions by the CGI
timeFrame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of 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: PRINCIPAL_INVESTIGATOR
References: