Treatment of Negative Symptoms of Schizophrenia by rTMS

Last updated: September 12, 2024
Sponsor: Centre hospitalier de Ville-Evrard, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tourette's Syndrome

Psychosis

Mood Disorders

Treatment

repetitive Transcranial Magnetic Stimulation

Clinical Study ID

NCT06595654
2021-A02710-40
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patient over 18 years of age

  • Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic andStatistical 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 havingsigned an informed consent

  • Patient fluent in the French language

  • Affiliation to a social security scheme

Exclusion

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

Study Design

Total Participants: 124
Treatment Group(s): 1
Primary Treatment: repetitive Transcranial Magnetic Stimulation
Phase:
Study Start date:
June 09, 2023
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • Etablissement Public de Santé de Ville-Evrard

    Neuilly-sur-Marne, 93330
    France

    Active - Recruiting

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