Using rTMS to treat negative symptoms of schizophrenia
Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study
This study is testing if a new type of brain treatment called rTMS can help reduce negative symptoms in people with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de Ville-Evrard, France Academic / other |
| Locations | 1 site (Neuilly-sur-Marne) |
| Trial ID | NCT06595654 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) in alleviating negative symptoms associated with schizophrenia in real-world settings. It proposes four different rTMS protocols tailored to individual patient tolerances, with treatment durations ranging from 2 to 4 weeks. Following the treatment, participants will be monitored for a period of 3 months to assess any relapses in symptoms, using the Scale for the Assessment of Negative Symptoms (SANS) for evaluation. The study aims to establish a regulatory framework for rTMS treatments under these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 diagnosed with schizophrenia who exhibit persistent negative symptoms and are stable on their medication.
Not a fit: Patients with contraindications to TMS, such as those with intracranial foreign bodies or unstable medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from negative symptoms of schizophrenia.
How similar studies have performed: Previous studies have shown promise in using rTMS for treating negative symptoms of schizophrenia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years of age * Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013) * Stable drug treatment for at least 4 weeks * Presence or persistence of negative symptoms in the foreground: Negative PANSS score ⩾21, positive PANSS score ⩽24 * Patient (or legal representative) willing to participate in the study and having signed an informed consent * Patient fluent in the French language * Affiliation to a social security scheme Exclusion Criteria: * Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker * Presence of an unstabilized medical condition * Pregnant woman * Woman of childbearing potential and without effective contraception * Breastfeeding woman
Where this trial is running
Neuilly-sur-Marne
- Etablissement Public de Santé de Ville-Evrard — Neuilly-sur-Marne, France (Recruiting)
Study contacts
- Principal investigator: Dominique Januel — Clinical research unit, EPS Ville Evrard
- Study coordinator: Youcef Bencherif
- Email: urc@epsve.fr
- 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.