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

NCT ID: NCT06451809

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2025-06-01

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.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

repetitive transcranial magnetic stimulation

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS CIPS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fariba Kabirian, MD

Role: PRINCIPAL_INVESTIGATOR

France Chief Medical Officer, Clariane

Locations

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 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

Countries

France

Other Identifiers

DEP&MOD

Identifier Type: -

Identifier Source: org_study_id