Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451835
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-29
Brief Title:
Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation Using Vocal Biomarkers
Sponsor:
GCS CIPS
Organization:
GCS CIPS
Study Overview
Official Title:
Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation rTMS for the Treatment of Major Depressive Disorder Using Vocal Biomarkers
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:
SPEECHTMS
Brief Summary:
Voice recordings taken prior to the start of repetitive transcranial magnetic stimulation rTMS therapy will be used to develop a predictive model of treatment response using machine learning for patients with major depressive disorders MDD
Detailed Description:
The objective of this study is to investigate whether voice biomarkers taken prior to the start of rTMS can predict the response to a 30-session course of rTMS in patients with 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 commencement of the rTMS course patients will need to complete several questionnaires Before the first session voice tests will be recorded using the Callyope application Patients will answer questionnaires and assess voice tests 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