Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323486
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-14
Brief Title:
Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression
Sponsor:
Ontario Shores Centre for Mental Health Sciences
Organization:
Ontario Shores Centre for Mental Health Sciences
Study Overview
Official Title:
Effects of Accelerated Bilateral Sequential Theta Burst Stimulation on Dual-task Cost Depression Cognition and Other Outcomes in Older Adults With Treatment-resistant Depression A Randomized Double-blind Sham-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
CogniTReaD
Brief Summary:
The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation absTBS and sham or inactive treatment The goal is to see if absTBS can help older adults with treatment-resistant depression TRD by looking at dual-task cost and mood as well as other cognitive functions anxiety levels quality of life and physical performance while also checking for any treatment side effects The study will recruit participants who will receive different study treatments in a specific order The study will be double-blinded meaning neither the participants nor the researchers will know who is receiving which treatment The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression This study seeks to discover if absTBS can modify a dementia risk marker ie dual-task cost and depression in older patients with TRD and to determine the effect size for larger investigations in the future
Detailed Description:
The CogniTReaD study is a two-arm sham-controlled double-blinded treatment-sequenced randomized clinical trial that will evaluate and explore the effects and safety of accelerated bilateral sequential theta burst stimulation absTBS compared to sham control in terms of improving dual-task cost cognitive functions depression other outcomes anxiety health-related quality of life activities of daily living global impression and other gait performance and occurrence of adverse events AE measured at Week 2 ie posttreatment acute effects in older adults with treatment-resistant depression TRD We shall also evaluate the effects and safety of absTBS on improving dual-task cost cognitive functions depression and occurrence of AE in terms of AE occurrences measured at Week 6 Week 8 and Week 10 ie posttreatment delayed effects in older adults with TRD
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