Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451809
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-29
Brief Title:
Prediction of the Response to a Course of Transcranial Magnetic Stimulation rTMS Based on Heart Rate Variability
Sponsor:
GCS CIPS
Organization:
GCS CIPS
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEPMOD
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None