Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on Heart Rate Variability

Major Depressive Disorder Clinical Trial

— DEP&MOD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451809
• Other study ID #: DEP&MOD
• Status: Recruiting
• Start date: June 13, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: GCS CIPS
• Contact: Nelly Heraud, PhD
• Phone: +33 (4) 68 68 69 60
• Email: nelly.heraud[@]clariane.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 1, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• repetitive transcranial magnetic stimulation
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).

Locations

Country	Name	City	State
France	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	Neuilly-sur-Marne
France	Centre médical de psychiatrie NeuroStim Etoile	Paris
France	Centre médical de psychiatrie NeuroStim Luxembourg	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

Sponsors (1)

Lead Sponsor	Collaborator
GCS CIPS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-evaluation of depressive symptoms	PHQ9 questionnaire	6 weeks (baseline and weekly records)
Other	Sleep quality	PSQI questionnaire	6 weeks (baseline and after the course of 30 rTMS sessions)
Other	Physical activity and sedentary behaviors	SIMPAQ questionnaire	6 weeks (baseline and after the course of 30 rTMS sessions)
Primary	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)
Secondary	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%)	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	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)