Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia
Recruiting · NCT06599372 · Interventional (participants receive a specific treatment) · Lead sponsor: Dominique JANUEL
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Etablissement Public de Santé de Ville-Evrard - Neuilly-sur-Marne, France