Treatment of Negative Symptoms of Schizophrenia by rTMS
Recruiting · NCT06595654 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre hospitalier de Ville-Evrard, France
View the official record on ClinicalTrials.gov →Interventions studied
repetitive Transcranial Magnetic Stimulation
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Etablissement Public de Santé de Ville-Evrard - Neuilly-sur-Marne, France