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

NCT06451835 | Suspended

• 1 other identifier: SPEECHTMS
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 9

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Area under the curve of the rTMS remission prediction model

  6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)

• Area under the curve of the prediction model of the self-assessed response to the rTMS course

  6 weeks : before the first session of rTMS (vocal samples) and each week during the rTMS treatment (PHQ-9 score)

• Area under the curve of the prediction model of the response to the rTMS course, trained with the addition of weekly recorded voice samples.

  6 weeks : weekly

• Area under the curve of the model predicting the response to rTMS treatment, trained with the addition of clinical indicators

  6 weeks : before the first session of rTMS (vocal samples) and before and after or weekly (clinical indicators)

• Comparison between the scores predicted by the model and the actual scores obtained on the different questionnaires assessed.

  6 weeks : before the first session of rTMS (vocal samples) and before and after the treatment (questionnaires)

Other Outcomes (8)

• Self-evaluation of depressive symptoms

  6 weeks : weekly

• Generalised Anxiety Disorder

  6 weeks : weekly

• Athens Insomnia Scale

  6 weeks : before and after rTMS treatment

Study Arms (1)

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

Device: repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS) 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).

Patients with MDD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• GCS CIPS: lead
• Callyope: collaborator

Study Sites (9)

Clinique Inicea du Pays de Seine

Bois-le-Roi, 77590, France

Location

Clinique Inicea La Mare O Dans

Les Damps, 27340, France

Location

Clinique Inicea Villa des Roses

Lyon, 69005, France

Location

Etablissement public de santé de Ville-Evrard

Neuilly-sur-Marne, 93330, France

Location

Centre médical de psychiatrie NeuroStim Luxembourg

Paris, 75005, France

Location

Centre médical de psychiatrie NeuroStim Etoile

Paris, 75016, France

Location

Clinique Inicea Jeanne d'Arc Hopital Privé Parisien

Saint-Mandé, 94160, France

Location

Centre montois de psychiatrie ambulatoire Inicea

Saint-Pierre-du-Mont, 40280, France

Location

Centre Tourangeau de psychiatrie ambulatoire Inicea

Tours, 37000, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Fariba KABIRIAN, MD

  France Chief Medical Officer, Clariane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 11, 2024
• Study Start: June 13, 2024
• Primary Completion: April 15, 2025
• Study Completion: June 15, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

FR (9)