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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-13

Study Completion Date

2025-06-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with MDD

Patients who are prescribed a course of 30 rTMS sessions to treat an episode of MDD at one of the nine participating centres

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No