Informations générales (source: ClinicalTrials.gov)
Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder Using Vocal Biomarkers (SPEECHTMS)
Observational
GCS CIPS (Voir sur ClinicalTrials)
juin 2024
juin 2025
05 avril 2025
Voice recordings taken prior to the start of repetitive transcranial magnetic stimulation
(rTMS) therapy will be used to develop a predictive model of treatment response using
machine learning for patients with major depressive disorders (MDD).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| ET.PUBLIC DE SANTE VILLE-EVRARD | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre médical de psychiatrie NeuroStim Etoile - 75016 - Paris - France | Contact (sur clinicalTrials) | ||||
| Centre médical de psychiatrie NeuroStim Luxembourg - 75005 - Paris - France | Contact (sur clinicalTrials) | ||||
| Centre montois de psychiatrie ambulatoire Inicea - 40280 - Saint-Pierre-du-Mont - France | Contact (sur clinicalTrials) | ||||
| Centre Tourangeau de psychiatrie ambulatoire Inicea - 37000 - Tours - France | Contact (sur clinicalTrials) | ||||
| Clinique Inicea du Pays de Seine - 77590 - Bois-le-Roi - France | Contact (sur clinicalTrials) | ||||
| Clinique Inicea Jeanne d'Arc Hopital Privé Parisien - 94160 - Saint-Mandé - France | Contact (sur clinicalTrials) | ||||
| Clinique Inicea La Mare O Dans - 27340 - Les Damps - France | Contact (sur clinicalTrials) | ||||
| Clinique Inicea Villa des Roses - 69005 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Having a prescription for a course of rTMS to treat an episod of MDD
- Unipolar MDD confirmed according to DSM-5 criteria
- Moderate to severe MDD (MADRS score > 19)
- No use of psychotropic medication or use stabilised (no change in dose < 4 weeks
before study entry)
- Able to understand, speak, read and write French
- Express informed consent, after a period of reflection
- Affiliated with a French social security scheme or beneficiary of such a scheme
- Having a prescription for a course of rTMS to treat an episod of MDD
- Unipolar MDD confirmed according to DSM-5 criteria
- Moderate to severe MDD (MADRS score > 19)
- No use of psychotropic medication or use stabilised (no change in dose < 4 weeks
before study entry)
- Able to understand, speak, read and write French
- Express informed consent, after a period of reflection
- Affiliated with a French social security scheme or beneficiary of such a scheme
- History of epilepsy or convulsive seizures
- Previous brain surgery
- History of recent cranial trauma (< 6 months)
- Presence of severe suicidal ideation
- Psychotic disorders
- Metal objects in the head, eyes or brain
- Implanted ferromagnetic equipment (pace maker, cochlear implant, etc.)
- Clinical evidence of serious or uncontrolled alcohol or substance use disorders in
the three months prior to the study
- Active withdrawal from alcohol or other substances
- One or more recent rTMS sessions (< 4 weeks)
- Other non-drug therapy recently initiated (< 4 weeks) to treat EDC (psychotherapy,
phototherapy, vagus nerve stimulation, etc.)
- Pathology altering phonation based on the perception of the investigator
- Subjects in a period of relative exclusion from another protocol
- Adults protected by law or patients under guardianship or curatorship
- Subjects deprived of their liberty by judicial or administrative decision
- Pregnant or breast-feeding women