Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534684
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-25
Brief Title:
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation iTBS Treatment for Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation iTBS Treatment for Depression A Randomised Double-blind Sham-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation iTBS compared to sham iTBS when targeting the left dorsolateral prefrontal cortex LDLPFC in clinically depressed outpatients The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS
Detailed Description:
The study is a randomized sham controlled double blind clinical trial in which the changes in cortical functions associated with the anti-depressive effect of two weeks of once-a-day neuronavigated iTBS over the left dorsolateral prefrontal cortex LDLPFC will be investigated in comparison to sham iTBS Participants will be recruited prospectively and the study is performed at a single university hospital After written informed consent is obtained from eligible volunteering patients baseline measurements will be administrated and the patient will be allocated to either sham or active iTBS once a day for 10 consecutive workdays A total of three measurements will take place namely at baseline prior to iTBS treatment after two weeks with iTBS treatment posttest and four weeks after follow-up The primary outcome measures will be assessed from baseline to the posttest
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None