Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05008198
Status:
RECRUITING
Last Update Posted:
2023-08-15
First Post:
2021-07-30
Brief Title:
Assessing an EEG Biomarker of Response to TMS for Major Depression
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Assessing an Electroencephalography EEG Biomarker of Response to Transcranial Magnetic Stimulation for Major Depression
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Veterans with treatment resistant depression TRD have the opportunity to receive transcranial magnetic stimulation TMS treatment via the VAs National TMS Clinical Pilot Program While some see improvement with their depression others do not Therefore it may be beneficial to be able to predict with biomarkers what participants may see improvement with their treatment Electroencephalography EEG is a means to identify such biomarkers Four hundred Veterans with TRD will be enrolled in this trial to determine whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation TMS can be prospectively replicated in a large ecologically valid sample Participants will have a total of EEG scans at baseline every 5th treatment session and at the end of treatment for a total of 7 EEG scans
Detailed Description:
The goals of this study are to 1 test a potential predictive resting EEG biomarker of antidepressant response differential patters of gamma oscillations in a large sample of Veterans with TRD receiving TMS N400 2 assess whether a second putative biomarker early changes in theta cordance during treatment predict eventual response to TMS as well as leverage this large sample to identify other potential biomarkers such as markers of early versus late response to TMS markers of response to other TMS parameters eg 5 Hz 1 Hz or theta burst TMS and markers of change with treatment that may speak to mechanism and 3 create an infrastructure to rapidly identify and test additional EEG-based biomarkers of treatment response in patients with depression and other psychiatric conditions
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?:
False
Is an FDA AA801 Violation?:
None