Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06599372

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

Led by Dominique JANUEL · Updated on 2024-09-19

30

Participants Needed

1

Research Sites

277 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 resistant auditory hallucinations despite 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 (b2HCG)
Not Eligible

You will not qualify if you...

  • Contraindication to magnetic stimulation such as intracranial foreign body, unstabilized epilepsy, or cochlear implant
  • Presence of an unstabilized medical condition
  • Pregnant woman or women of childbearing age without effective contraception
  • Current or less than one month old participation in another research protocol
  • Person subject to a safeguard of justice measure
  • Adult under curatorship
  • Minor patients with mental health problems
  • Pregnant or breastfeeding women
  • Person in social fragility (including persons deprived of liberty or hospitalized persons)
  • Persons incapable or unable to give consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Etablissement Public de Santé de Ville-Evrard

Neuilly-sur-Marne, France, 93330

Actively Recruiting

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Research Team

Y

Youcef Bencherif

CONTACT

R

Rusheentira Thavaseelan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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