Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation Using Vocal Biomarkers

Major Depressive Disorder Clinical Trial

— SPEECHTMS  

Official title:

Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder Using Vocal Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451835
• Other study ID #: SPEECHTMS
• Status: Recruiting
• Start date: June 13, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: June 2024
• Source: GCS CIPS
• Contact: Nelly HERAUD, PhD
• Phone: +33468686960
• Email: nelly.heraud[@]clariane.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• repetitive transcranial magnetic stimulation (rTMS)
rTMS will be applied 5 days out of 7 for 6 weeks, for a total of 30 sessions. The area stimulated will be the left dorsolateral prefrontal cortex, at a frequency of 10 Hz, at 110% of motor threshold for approximately 20 minutes (i.e. 3,000 stimulations per session).

Locations

Country	Name	City	State
France	Clinique Inicea du Pays de Seine	Bois-le-Roi
France	Clinique Inicea La Mare O Dans	Les Damps
France	Clinique Inicea Villa des Roses	Lyon
France	Etablissement public de santé de Ville-Evrard	Neuilly-sur-Marne
France	Centre médical de psychiatrie NeuroStim Etoile	Paris
France	Centre médical de psychiatrie NeuroStim Luxembourg	Paris
France	Clinique Inicea Jeanne d'Arc Hopital Privé Parisien	Saint-Mandé
France	Centre montois de psychiatrie ambulatoire Inicea	Saint-Pierre-du-Mont
France	Centre Tourangeau de psychiatrie ambulatoire Inicea	Tours

Sponsors (2)

Lead Sponsor	Collaborator
GCS CIPS	Callyope

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-evaluation of depressive symptoms	PHQ-9 questionnaire	6 weeks : weekly
Other	Generalised Anxiety Disorder	GAD-7 questionnaire	6 weeks : weekly
Other	Athens Insomnia Scale	AIS questionnaire	6 weeks : before and after rTMS treatment
Other	Instrumental Activities of Daily Living (autonomy)	IADL	6 weeks : before and after rTMS treatment
Other	Motivation and Pleasure Scale - Self Report (anhedonia)	MAP-SR	6 weeks : before and after rTMS treatment
Other	Social Network Index	SNI	before rTMS treatment
Other	Loneliness Scale	UCLA 3-Items	before rTMS treatment
Other	Simple physical activity questionnaire	SIMPAQ	6 weeks : before and after rTMS treatment
Primary	Area under the curve of the model predicting response to rTMS treatment	Area under the curve of the model predicting response to rTMS treatment, objectified by a 50% reduction in MADRS depression score, trained from vocal biomarkers recorded before rTMS treatment.	6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)
Secondary	Area under the curve of the rTMS remission prediction model	Area under the curve of the rTMS remission prediction model, objectified by a post-course MADRS score lower than 10, trained from vocal biomarkers recorded before the rTMS course.	6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)
Secondary	Area under the curve of the prediction model of the self-assessed response to the rTMS course	Area under the curve of the prediction model of the self-assessed response to the rTMS course, objectified by a 50% reduction in PHQ-9 depression score, trained from the vocal biomarkers recorded before the rTMS course.	6 weeks : before the first session of rTMS (vocal samples) and each week during the rTMS treatment (PHQ-9 score)
Secondary	Area under the curve of the prediction model of the response to the rTMS course, trained with the addition of weekly recorded voice samples.	Area under the curve of the prediction model of the response to the rTMS course, trained with the addition in the initial model of vocal biomarkers recorded each week of the rTMS course.	6 weeks : weekly
Secondary	Area under the curve of the model predicting the response to rTMS treatment, trained with the addition of clinical indicators	Area under the curve of the model predicting the response to rTMS treatment, trained with the addition in the initial model of clinical indicators other than depression.	6 weeks : before the first session of rTMS (vocal samples) and before and after or weekly (clinical indicators)
Secondary	Comparison between the scores predicted by the model and the actual scores obtained on the different questionnaires assessed.	Coefficients of determination R² and average absolute errors between the scores predicted by the model and the actual scores obtained on the different PHQ-9, GAD-7, IADL, AIS and MAP-SR questionnaires.	6 weeks : before the first session of rTMS (vocal samples) and before and after the treatment (questionnaires)
Secondary	Area under the curve of the different prediction models obtained, starting from pre-trained models on healthy subject databases.	Area under the curve of the different prediction models obtained, starting from pre-trained models on healthy subject databases.	6 weeks : Before and after rTMS treatment
Secondary	Risk and coverage of the different prediction models obtained.	Risk and coverage of the different prediction models obtained.	6 weeks : After rTMS treatment
Secondary	Comparison of the prediction models obtained with or without the use of advanced data encryption algorithms.	Comparison of the areas under the curve of the different prediction models obtained with or without the use of advanced data encryption algorithms.	6 weeks : After rTMS treatment