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

Dominique JANUEL

Status: Enrolling

Conditions: Schizophrenia; Transcranial Magnetic Stimulation; Hallucinations, Verbal Auditory

Treatments: Other: The rTMS method; Other: The cTBS method

Study type: Interventional

Funder types: Other

Identifiers

NCT06599372

2021-A02698-33

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

The rTMS method

Other group

Description:

The treatment lasts 2 weeks with 20 rTMS sessions at a rate of 2 sessions per day. Each session lasts 20 minutes with a one hour break between sessions. The application of rTMS will be done on the left temporo-parietal junction.

Treatment:

Other: The rTMS method

The cTBS method

Other group

Description:

The treatment lasts 15 days with 45 sessions of cTBS at a rate of 3 sessions per day. The session lasts 40 seconds and consists of 3 pulses at 50Hz repeated every 200 milliseconds (5Hz) to reach a total of 600 pulses, with a 15 minute break between sessions. The application of cTBS will be performed on the left temporo-parietal junction.

Treatment:

Other: The cTBS method