NCT06595654Recruiting
Treatment of Negative Symptoms of Schizophrenia by rTMS
Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 24 Jul 2024
- Start date
- 9 Jun 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Diseases
- Schizophrenia
- NCT number
- NCT06595654
What you commit to
- Study type: Interventional
- Planned participants: 124
- From 9 Jun 2023 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
- Presence of an unstabilized medical condition
Other
- Pregnant woman
- Woman of childbearing potential and without effective contraception
- Breastfeeding woman
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Etablissement Public de Santé de Ville-Evrard Coordinator of this site? Confirm its status | Neuilly-sur-Marne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.