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).
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.
Study Type
OBSERVATIONAL
Enrollment
160
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).
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
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.
Threshold of variation in terms of RMSSD (root mean square of successive differences) between normal heartbeats after a single rTMS session enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity. The response to the course of rTMS will be assessed via the evolution of the MADRS score (decrease of MADRS score \>50%)
Time frame: 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)
Threshold of other heart rate variability markers enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
Threshold of variation in other heart rate variability markers (SDNN, low frequencies, high frequencies and low to high frequencies ratio) after a single rTMS session enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity. The response to the course of rTMS will be assessed via the evolution of the MADRS score (decrease of MADRS score \>50%)
Time frame: 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)
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.
Threshold of variation in heart rate variability markers (RMSSD, SDNN, low frequencies, high frequencies and low to high frequencies ratio) after a single rTMS session enabling to predict the remission to the course of rTMS with the best possible sensitivity and specificity. The remission to the course of rTMS will be assessed via the evolution of the MADRS score (MADRS ≤ 10 after the course of rTMS)
Time frame: 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)
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Neuilly-sur-Marne, France
Centre médical de psychiatrie NeuroStim Luxembourg
Paris, France
Centre médical de psychiatrie NeuroStim Etoile
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, France