Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Centre hospitalier de Ville-Evrard, France
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Dominique JANUEL
Head of clinical research unit
Centre hospitalier de Ville-Evrard, France
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
Outcomes
Primary Outcomes
Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).
Time Frame: Baseline (day 1) to end of treatment (2 or 4 weeks)
The SANS is a scale used for negative symptoms that is initially made up of 19 items divided into five sub-scales: emotional blunder, pedigree, avolition-apathy, anhedonia and social withdrawal. Based on the percentage reduction of this score after 2-4 weeks, patients will be allocated according to the following criteria: * Remission: 75% * Effective treatment: 50-74% * Improvement/response: 25-49% * No answer: \<25%
Secondary Outcomes
- Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI.(Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.)
- Assess the impact of this treatment on response rate by the SANS(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on the rate of remission by the number of remission with the SANS(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on the relapse rate by the number of relapse with SANS(4 weeks, 12 weeks and 24 weeks after the end of treatment.)
- Assess the impact of this treatment on cognitive symptoms by MOCA (Montreal Cognitive Assessment) and STROOP(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on addictive attitudes by MCQ (Marijuana Craving Questionnaire) and CAST (Cannabis Abuse Screening Test)(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on mood by CDSS (Calgary Depression Scale for Schizophrenia).(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on quality of life by S-QoL-18(Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.)
- Assess the impact of this treatment on adverse reactions by the CGI(Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.)