Treatment of Negative Symptoms of Schizophrenia by rTMS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de Ville-Evrard, France
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Patient (or legal representative) willing to participate in the study and having signed an informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
repetitive Transcranial Magnetic Stimulation
Other intervention* Patient is in a chair. * Hearing protection will be implemented. * The corresponding targeting method will be implemented. * The stimulation coil will be set up according to the indications of the targeting method. * A caregiver is present throughout the session. * After the session, the patient is re-assessed clinically for possible adverse effects. * If an adverse reaction is objectified, a doctor on site, is quickly mobilized.
Treatment groups
124 Participants
are divided into 4 treatment groupsGroup A: Method 1Other 1 intervention
Group B: Method 2Other 1 intervention
Group C: Method 3Other 1 intervention
Group D: Method 4Other 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).
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%
Time frame
Baseline (day 1) to end of treatment (2 or 4 weeks)Secondary outcomes
1
Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI.
The PANSS (Positive and Negative Syndrome Scale) is composed of 3 parts: positive symptoms, negative symptoms and general psychopathology. The last part consists of 16 items. The score can range from 16 to 112. The CGI (Clinical Global Impression) is a 3-item scale: the severity of the disease, the overall improvement and the efficiency index. The first two items are scored from 0 to 7, and the last in a 4x4 table.
Time frame
Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.2
Assess the impact of this treatment on response rate by the SANS
The Scale for the Assessment of Negative Symptoms (SANS) splits assessment into five domains (Affective flattening, Alogia, Avolition, Anhedonia, Attention). Within each domain it rates separate symptoms from 0 (absent) to 5 (severe). The response is defined by a 25-49% reduction in the initial score.
Time frame
Baseline (day 1) to end of treatment (2 or 4 weeks)3
Assess the impact of this treatment on the rate of remission by the number of remission with the SANS
The Scale for the Assessment of Negative Symptoms (SANS) splits assessment into five domains (Affective flattening, Alogia, Avolition, Anhedonia, Attention). Within each domain it rates separate symptoms from 0 (absent) to 5 (severe). Based on the percentage reduction of this score after 2-4 weeks, patients will be considered in remission if they have a 75% reduction..
Time frame
Baseline (day 1) to end of treatment (2 or 4 weeks)4
Assess the impact of this treatment on the relapse rate by the number of relapse with SANS
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%
Time frame
4 weeks, 12 weeks and 24 weeks after the end of treatment.Sponsors and contacts
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Source ClinicalTrials.gov