Evaluating Transcranial Magnetic Stimulation for Auditory Hallucinations in Schizophrenia
Treatment of Resistant Auditory Hallucinations in Schizophrenia by Repetitive Transcranial Magnetic Stimulation. Naturalistic Study
NA · Centre hospitalier de Ville-Evrard, France · NCT06599372
This study is testing if two types of brain stimulation can help people with schizophrenia who have trouble with persistent auditory hallucinations feel better while they continue their regular medication.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de Ville-Evrard, France (other) |
| Locations | 1 site (Neuilly-sur-Marne) |
| Trial ID | NCT06599372 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) and continuous Theta Burst Stimulation (cTBS) in treating resistant auditory hallucinations in patients diagnosed with schizophrenia. It aims to assess the improvement of these hallucinations using the Auditory Hallucination Rating Scale (AHRS) in a naturalistic clinical setting, alongside standard antipsychotic treatments. Participants will be monitored for changes in their symptoms from baseline to the end of the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with schizophrenia who experience resistant auditory hallucinations despite treatment with at least two different antipsychotics.
Not a fit: Patients with contraindications to magnetic stimulation, such as those with intracranial foreign bodies or unstabilized epilepsy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the severity of auditory hallucinations in patients with schizophrenia who have not responded to traditional medications.
How similar studies have performed: Previous studies have shown promising results with rTMS for treating auditory hallucinations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Neuilly-sur-Marne
- Etablissement Public de Santé de Ville-Evrard — Neuilly-sur-Marne, France (RECRUITING)
Study contacts
- Principal investigator: Noomane BOUAZIZ — Clinical research unit, EPS Ville Evrard
- Study coordinator: Youcef Bencherif
- Email: urcve1@gmail.com
- Phone: +33 1 43 09 32 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia, Transcranial Magnetic Stimulation, Hallucinations, Verbal Auditory, hallucinations, resistant auditory hallucinations, schizophrenia, TMS, Transcranial magnetic stimulation