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

GCS CIPS

Status

Suspended

Conditions

Major Depressive Disorder

Treatments

Device: repetitive transcranial magnetic stimulation

Study type

Observational

Funder types

Other

Identifiers

NCT06451809

DEP&MOD

Details and patient eligibility

About

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).

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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