RecruitingNot ApplicableNCT06595654

Treatment of Negative Symptoms of Schizophrenia by rTMS

Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study


Sponsor

Centre hospitalier de Ville-Evrard, France

Enrollment

124 participants

Start Date

Jun 9, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria5

  • 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

Interventions

OTHERrepetitive Transcranial Magnetic Stimulation

* 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.


Locations(1)

Etablissement Public de Santé de Ville-Evrard

Neuilly-sur-Marne, France

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NCT06595654


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