Clinical trial NCT06451835: Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation Using Vocal Biomarkers
Official title: Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder Using Vocal Biomarkers
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Major Depressive Disorder
Lead sponsor: GCS CIPS
Sponsor class: OTHER
Collaborators: name: Callyope
First posted: 2024-06-11
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients recruited will be patients admitted as outpatients to treat MDD through a rTMS treatment in one of the 9 investigation centers.

Brief summary: 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).

Detailed description: The objective of this study is to investigate whether voice biomarkers taken prior to the start of rTMS can predict the response to a 30-session course of rTMS in patients with MDD with good sensitivity and specificity. Patients who are prescribed rTMS to treat an episode of MDD at one of the nine participating centres will be invited to participate in the study. The protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rTMS. The rTMS course will last for six weeks, comprising of 30 sessions with five sessions per week. Prior to the commencement of the rTMS course, patients will need to complete several questionnaires. Before the first session, voice tests will be recorded using the Callyope application. Patients will answer questionnaires and assess voice tests weekly and after the final rTMS session to track the progression of depressive symptoms.

Eligibility criteria: 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Area under the curve of the model predicting response to rTMS treatment
timeFrame: 6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)
Secondary outcomes:
measure: Area under the curve of the rTMS remission prediction model
timeFrame: 6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)
measure: Area under the curve of the prediction model of the self-assessed response to the rTMS course
timeFrame: 6 weeks : before the first session of rTMS (vocal samples) and each week during the rTMS treatment (PHQ-9 score)
measure: Area under the curve of the prediction model of the response to the rTMS course, trained with the addition of weekly recorded voice samples.
timeFrame: 6 weeks : weekly
measure: Area under the curve of the model predicting the response to rTMS treatment, trained with the addition of clinical indicators
timeFrame: 6 weeks : before the first session of rTMS (vocal samples) and before and after or weekly (clinical indicators)
measure: Comparison between the scores predicted by the model and the actual scores obtained on the different questionnaires assessed.
timeFrame: 6 weeks : before the first session of rTMS (vocal samples) and before and after the treatment (questionnaires)
measure: Area under the curve of the different prediction models obtained, starting from pre-trained models on healthy subject databases.
timeFrame: 6 weeks : Before and after rTMS treatment
measure: Risk and coverage of the different prediction models obtained.
timeFrame: 6 weeks : After rTMS treatment
measure: Comparison of the prediction models obtained with or without the use of advanced data encryption algorithms.
timeFrame: 6 weeks : After rTMS treatment
Other outcomes:
measure: Self-evaluation of depressive symptoms
timeFrame: 6 weeks : weekly
measure: Generalised Anxiety Disorder
timeFrame: 6 weeks : weekly
measure: Athens Insomnia Scale
timeFrame: 6 weeks : before and after rTMS treatment
measure: Instrumental Activities of Daily Living (autonomy)
timeFrame: 6 weeks : before and after rTMS treatment
measure: Motivation and Pleasure Scale - Self Report (anhedonia)
timeFrame: 6 weeks : before and after rTMS treatment
measure: Social Network Index
timeFrame: before rTMS treatment
measure: Loneliness Scale
timeFrame: before rTMS treatment
measure: Simple physical activity questionnaire
timeFrame: 6 weeks : before and after rTMS treatment
Locations:
city: Bois-le-Roi
country: France
facility: Clinique Inicea du Pays de Seine
city: Les Damps
country: France
facility: Clinique Inicea La Mare O Dans
city: Lyon
country: France
facility: Clinique Inicea Villa des Roses
city: Neuilly-sur-Marne
country: France
facility: Etablissement public de santé de Ville-Evrard
city: Paris
country: France
facility: Centre médical de psychiatrie NeuroStim Luxembourg
city: Paris
country: France
facility: Centre médical de psychiatrie NeuroStim Etoile
city: Saint-Mandé
country: France
facility: Clinique Inicea Jeanne d'Arc Hopital Privé Parisien
city: Saint-Pierre-du-Mont
country: France
facility: Centre montois de psychiatrie ambulatoire Inicea
city: Tours
country: France
facility: Centre Tourangeau de psychiatrie ambulatoire Inicea
Study officials:
affiliation: France Chief Medical Officer, Clariane
name: Fariba KABIRIAN, MD
role: PRINCIPAL_INVESTIGATOR
References: