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Recruiting NCT06595654

Treatment of Negative Symptoms of Schizophrenia by rTMS

No phase Interventional Schizophrenia Negative Symptoms in Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: repetitive Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Schizophrenia, Negative Symptoms in Schizophrenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Other repetitive 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (9)
  • Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI. [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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). [Time frame: 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 [Time frame: 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 [Time frame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Etablissement Public de Santé de Ville-Evrard — Neuilly-sur-Marne

Identifiers

NCT: NCT06595654 · 2021-A02710-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗