Using rTMS to treat resistant auditory hallucinations in schizophrenia

Structural and Functional Correlates of Clinical Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Schizophrenia Patients With Resistant Auditory Hallucinations

This study is testing if a new brain treatment called rTMS can help people with schizophrenia who still hear voices despite other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Centre hospitalier de Ville-Evrard, France (Academic / other)
• Locations: 1 site (Neuilly-sur-Marne,)
• Trial ID: NCT02755623 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on patients with schizophrenia who experience resistant auditory hallucinations. It aims to understand the structural and functional brain changes associated with rTMS treatment, focusing on the left temporoparietal junction. By analyzing individual responses to rTMS, the study seeks to enhance treatment efficacy and develop personalized therapeutic approaches. Participants will receive either active rTMS or a sham treatment to assess the impact on their symptoms.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 18 to 65 with a diagnosis of schizophrenia and resistant auditory hallucinations.

Not a fit: Patients with other psychiatric disorders, recent substance abuse, or contraindications to rTMS or MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce auditory hallucinations in patients with schizophrenia, improving their quality of life.

How similar studies have performed: Previous studies have shown promising results with rTMS for treating auditory hallucinations, but this study aims to address variability in treatment responses.

Eligibility criteria

Inclusion Criteria:

* Patient with a diagnosis of schizophrenia according to DSM-V (Diagnostic and Statistical Manual of Mental Disorder V, 2013) criteria
* Clinically stabilized for at least 3 months
* Patient with resistant auditory hallucinations
* Male or female, 18 to 65 years old
* A written agreement from the patient's legal guardian/s, if applicable
* Right-handed
* A good knowledge of the French language
* Signed consent form

Exclusion Criteria:

* Other diseases than schizophrenia
* Indulging in an addiction (alcohol, psychoactive substances) over the last 12 months
* Patient who has received rTMS treatment in the last 12 months
* Patient who is participating in a concurrent research protocol
* Patient with a history of seizures
* rTMS contraindications: patient with epilepsy, brain surgery and/or head trauma in the past, use of cardiac pacemaker, or surgical staples on the scalp
* MRI contraindications: pregnancy or lactating (n.b. a negative pregnancy test will be required if the patient is a female in reproductive years who does not use contraception); use of cardiac pace maker or surgical staples; patient with a neurological disorder, head trauma or claustrophobia
* Patient with severe cardiovascular disease
* Patient with medication which reduces the epileptic threshold (bupropion, methadone and theophylline)
* Patients placed in psychiatric care either by the state or a third party

Where this trial is running

Neuilly-sur-Marne,

• Unité de Recherche Clinique, EPS Ville Evrard — Neuilly-sur-Marne,, France (Recruiting)

Study contacts

• Principal investigator: Fanny Thomas, BIOLOGISTE — Unité de Recherche Clinique, EPS Ville Evrard, Neuilly-sur-Marne,, France, 93330
• Study coordinator: Arezki Ourrad

Conditions Schizophrenia