NCT06595654 Treatment of Negative Symptoms of Schizophrenia by rTMS
| NCT ID | NCT06595654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de Ville-Evrard, France |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2023-06-09 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2023-06-09 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).
Eligibility 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
Contact & Investigator
Dominique Januel
PRINCIPAL INVESTIGATOR
Clinical research unit, EPS Ville Evrard
Frequently Asked Questions
Who can join the NCT06595654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06595654 currently recruiting?
Yes, NCT06595654 is actively recruiting participants. Contact the research team at urc@epsve.fr for enrollment information.
Where is the NCT06595654 trial being conducted?
This trial is being conducted at Neuilly-sur-Marne, France.
Who is sponsoring the NCT06595654 clinical trial?
NCT06595654 is sponsored by Centre hospitalier de Ville-Evrard, France. The principal investigator is Dominique Januel at Clinical research unit, EPS Ville Evrard. The trial plans to enroll 124 participants.
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