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Recruiting NCT06599372

Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia

No phase Interventional Schizophrenia Transcranial Magnetic Stimulation Hallucinations, Verbal Auditory

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: The rTMS method, The cTBS method.
Who it may be relevant to
Registry conditions: Schizophrenia, Transcranial Magnetic Stimulation, Hallucinations, Verbal Auditory. 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 →

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Official title

Treatment of Resistant Auditory Hallucinations in Schizophrenia by Repetitive Transcranial Magnetic Stimulation. Naturalistic Study

Overview

This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS scale to evaluate the effectiveness of rTMS on RAH in patients with schizophrenia. Our main hypothesis is that rTMS used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the AHRS scale between baseline and end of treatment in patients with schizophrenia.

Interventions

  • Other The rTMS method
    The patient receives treatment under naturalistic conditions in routine practice.
  • Other The cTBS method
    The patient receives the treatment under naturalistic conditions in routine practice.

Primary outcome measures

  • The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale) [Time frame: Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment]
Secondary outcome measures (7)
  • Response rate: a response is defined as a decrease greater than or equal to 30% of total AHRS score from baseline to end of treatment. [Time frame: Baseline and at the end of the treatment]
  • Rate of patients with an end-of-treatment score < 3 on the Positive And Negative Syndrome Scale (PANSS) "Hallucinatory Behavior" item [Time frame: Baseline and at the end of the treatment]
  • Cognitive symptoms: Montreal Cognitive Assessment (MOCA), Stroop [Time frame: Baseline and 1 month after the end of treatment]
  • Addictive attitudes: number of cigarettes/d (tobacco), The Cannabis Abuse Screening Test (CAST), Marijuana Craving Questionnaire (MCQ) [Time frame: Baseline and at the end of the treatment]
  • Mood: Calgary Depression Scale for Schizophrenia (CDSS) [Time frame: Baseline and the end of the treatment]
  • Quality of life: The Subjective Quality of Life Scale (S-QoL) [Time frame: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment]
  • Clinical Global Impressions (CGI) Scale [Time frame: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment]

Eligibility criteria

Inclusion criteria

  • Patient over 18 years of age
  • Patient diagnosed with schizophrenia according to DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
  • Presence of auditory hallucinations: Resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics.
  • Patient agreeing to participate in the study and having signed an informed consent
  • Patient with French language skills
  • Affiliation to a social security system
  • Women of childbearing age must be on contraception and have a negative pregnancy test (βHCG)

Exclusion criteria

  • Have a contraindication to MST: intracranial foreign body, unstabilized epilepsy, cochlear implant
  • Presence of an unstabilized medical condition
  • Pregnant woman (Women of childbearing age without effective contraception)
  • Current or less than one month old engagement in another research protocol
  • A person who is subject to a safeguard of justice measure
  • An adult under curatorship
  • Minor patients with mental health problems
  • Pregnant or breastfeeding women
  • A person in a social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons)
  • Persons incapable or unable to give consent

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
Triple blind
Primary purpose
Treatment

Study locations

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

Identifiers

NCT: NCT06599372 · 2021-A02698-33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗