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We are faced with a decrease in rTMS activity at the study sites, as well as problems with the active file meeting the protocol inclusion criteria, resulting in a low recruitment rate and an extended study timetable, forcing us to suspend this study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive transcranial magnetic stimulation | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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%) | 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 | Description | Time Frame |
|---|---|---|
| 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%) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-evaluation of depressive symptoms | PHQ9 questionnaire | 6 weeks (baseline and weekly records) |
| Sleep quality | PSQI questionnaire | 6 weeks (baseline and after the course of 30 rTMS sessions) |
Inclusion Criteria:
Exclusion criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Fariba Kabirian, MD | France Chief Medical Officer, Clariane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Inicea du Pays de Seine | Bois-le-Roi | 77590 | France | |||
| Clinique Inicea La Mare O Dans |
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|
| 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) | 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) |
| Physical activity and sedentary behaviors | SIMPAQ questionnaire | 6 weeks (baseline and after the course of 30 rTMS sessions) |
| Les Damps |
| 27340 |
| France |
| Clinique Inicea Villa des Roses | Lyon | 69005 | France |
| Etablissement public de santé de Ville-Evrard | Neuilly-sur-Marne | 93330 | France |
| Centre médical de psychiatrie NeuroStim Luxembourg | Paris | 75005 | France |
| Centre médical de psychiatrie NeuroStim Etoile | Paris | 75016 | France |
| Clinique Inicea Jeanne d'Arc Hopital Privé Parisien | Saint-Mandé | 94160 | France |
| Centre montois de psychiatrie ambulatoire Inicea | Saint-Pierre-du-Mont | 40280 | France |
| Centre Tourangeau de psychiatrie ambulatoire Inicea | Tours | 37000 | France |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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