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

NCT06451809 | Suspended

• 1 other identifier: DEP&MOD
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 9

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Threshold of other heart rate variability markers enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.

  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.

  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)

Other Outcomes (3)

• Self-evaluation of depressive symptoms

  6 weeks (baseline and weekly records)

• Sleep quality

  6 weeks (baseline and after the course of 30 rTMS sessions)

• Physical activity and sedentary behaviors

  6 weeks (baseline and after the course of 30 rTMS sessions)

Study Arms (1)

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

Device: repetitive transcranial magnetic stimulation

Interventions

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).

Patients with MDD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• GCS CIPS: lead

Study Sites (9)

Clinique Inicea du Pays de Seine

Bois-le-Roi, 77590, France

Location

Clinique Inicea La Mare O Dans

Les Damps, 27340, France

Location

Clinique Inicea Villa des Roses

Lyon, 69005, France

Location

Etablissement public de santé de Ville-Evrard

Neuilly-sur-Marne, 93330, France

Location

Centre médical de psychiatrie NeuroStim Luxembourg

Paris, 75005, France

Location

Centre médical de psychiatrie NeuroStim Etoile

Paris, 75016, France

Location

Clinique Inicea Jeanne d'Arc Hopital Privé Parisien

Saint-Mandé, 94160, France

Location

Centre montois de psychiatrie ambulatoire Inicea

Saint-Pierre-du-Mont, 40280, France

Location

Centre Tourangeau de psychiatrie ambulatoire Inicea

Tours, 37000, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Fariba Kabirian, MD

  France Chief Medical Officer, Clariane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 11, 2024
• Study Start: June 13, 2024
• Primary Completion: April 15, 2025
• Study Completion: June 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

FR (9)