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

GCS CIPS

Status

Suspended

Conditions

Major Depressive Disorder

Treatments

Device: repetitive transcranial magnetic stimulation (rTMS)

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06451835

SPEECHTMS

Details and patient eligibility

About

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).

Full 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.

Enrollment

156 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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