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

Last updated: September 12, 2024
Sponsor: Dominique JANUEL
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Psychosis

Tourette's Syndrome

Treatment

The rTMS method

The cTBS method

Clinical Study ID

NCT06599372
2021-A02698-33
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient over 18 years of age

  • Patient diagnosed with schizophrenia according to DSM-V criteria (Diagnostic andStatistical Manual of Mental Disorder V5, 2013)

  • Presence of auditory hallucinations: Resistant auditory hallucinations: resistanceto 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 pregnancytest (βHCG)

Exclusion

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 oradministrative decision, hospitalized persons)

  • Persons incapable or unable to give consent

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: The rTMS method
Phase:
Study Start date:
July 11, 2022
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Etablissement Public de Santé de Ville-Evrard

    Neuilly-sur-Marne, 93330
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.