Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia
NCT ID: NCT06599372
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-07-11
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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The rTMS method
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.
The rTMS method
The patient receives treatment under naturalistic conditions in routine practice.
The cTBS method
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.
The cTBS method
The patient receives the treatment under naturalistic conditions in routine practice.
Interventions
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The rTMS method
The patient receives treatment under naturalistic conditions in routine practice.
The cTBS method
The patient receives the treatment under naturalistic conditions in routine practice.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Dominique JANUEL
OTHER
Responsible Party
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Dominique JANUEL
Head of clinical research unit
Principal Investigators
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Dominique JANUEL
Role: STUDY_DIRECTOR
Clinical research unit, EPS Ville Evrard
Noomane BOUAZIZ
Role: PRINCIPAL_INVESTIGATOR
Clinical research unit, EPS Ville Evrard
Locations
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Etablissement Public de Santé de Ville-Evrard
Neuilly-sur-Marne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A02698-33
Identifier Type: -
Identifier Source: org_study_id
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