NCT06451809

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

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: GCS CIPS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-04-15
• Completion: 2025-06-01
• First posted: 2024-06-11
• Last updated: 2025-03-12

Locations

9 sites across 1 country: France