Clinical trial NCT06451809: Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on Heart Rate Variability
Official title: Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on the Acute Variation in Heart Rate Variability Obtained After a Single RTMS Session in Patients with Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Major Depressive Disorder
Lead sponsor: GCS CIPS
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 160
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: Patients recruited will be patients who have been admitted as an outpatient for the treatment of MDD by rTMS treatment at one of the 9 study centres.

Brief summary: Changes in heart rate variability following a single session of rTMS will be tested as a predictor of response to a course of 30 rTMS sessions in patients with major depressive disorder (MDD).

Detailed description: The objective of this study is to investigate whether acute changes in heart rate variability following a single session of repetitive transcranial magnetic stimulation (rTMS) can predict the response to a 30-session course of rTMS in patients with major depressive disorder (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 start of the rTMS course, the patient will have to fill in a number of questionnaires. Before the first session, heart rate variability will be assessed by recording the RR interval at rest using a heart rate belt on the armchair stimulation. A second RR interval recording will be taken immediately after the first rTMS session. Patients will answer questionnaires 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 MDD (psychotherapy, phototherapy, vagus nerve stimulation, etc.)
* Prescription of cardiotropic drugs belonging to the following classes: predominantly cardiac calcium channel blockers, Vaughan Williams class I anti-arrhythmics and beta-blockers.
* 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: Threshold of variation in terms of RMSSD between normal heartbeats enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
timeFrame: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Secondary outcomes:
measure: Threshold of other heart rate variability markers enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
timeFrame: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
measure: Threshold of variation in heart rate variability markers enabling to predict the remission to the course of rTMS with the best possible sensitivity and specificity.
timeFrame: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Other outcomes:
measure: Self-evaluation of depressive symptoms
timeFrame: 6 weeks (baseline and weekly records)
measure: Sleep quality
timeFrame: 6 weeks (baseline and after the course of 30 rTMS sessions)
measure: Physical activity and sedentary behaviors
timeFrame: 6 weeks (baseline and after the course of 30 rTMS sessions)
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: