Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-27 @ 10:57 AM
Study NCT ID:
NCT05855850
Status:
COMPLETED
Last Update Posted:
2024-06-17
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep rTMS for Depression in Older Adults
Sponsor:
St. Joseph's Healthcare Hamilton
Organization:
Study Overview
Official Title:
DIfferential Feasibility and Tolerability of Deep repetitiVe transcranIal MagNEtic Stimulation for Depression in Older Adults (DIVINE Trial): A Pilot Study
Status:
COMPLETED
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:
None
Brief Summary:
This study aims to: (1) assess the feasibility and tolerability of two active dTMS coils - H4 and H7 - in older adults with depression; and (2) clinical response measured by change from baseline on the Hamilton Depression Rating Scale- 24 item; changes in cognitive function through neuropsychological assessment; and changes in regional electrophysiological activity and functional connectivity indexed by EEG. Through a parallel design, participants will complete a four-week course of five dTMS sessions per week, for a total of 20 stimulation sessions. Participants will be randomly assigned to either coil (H4 or H7) and will complete questionnaires examining side effects, mental health symptoms, and cognition. Participant EEG data will be measured and collected at baseline and at the end of each week. Collectively, the study will address the absolute and differential feasibility and tolerability of the two active coils to provide preliminary data for a future randomized controlled trial comparing one or both of these novel interventions to the established H1-coil and a sham stimulation (placebo) control.
Detailed Description:
Transcranial magnetic stimulation (TMS) is a non-invasive therapeutic technique used to stimulate regions of the brain using magnetic pulses. Repeated TMS delivers sequences of pulses for multiple days in a row and is an approved treatment for several psychiatric conditions. Deep TMS (dTMS) is a new technique that uses modified magnetic Hesed coils (H-coils) to stimulate deeper regions of the brain and has been FDA- and Health Canada-approved for major depressive disorder (MDD), obsessive-compulsive disorder, smoking cessation, and anxious-depression in adults. For older adults (60+), traditional rTMS has also shown efficacy for MDD (60+) and one RCT has found benefit for the H1 dTMS coil, but no trials have examined the H4 and H7 coils in this population. This innovative pilot study will explore dTMS feasibility and tolerability (i.e., side effects, impacts on mental health and cognition) of these two dTMS coils (H4, targeting insula and H7, targeting anterior cingulate cortex) in older adults with depression. The pilot will provide critical preliminary data for a future trial comparing these novel interventions to the H1-coil and a sham stimulation control. There is sparse literature examining the effects of dTMS on cognition, as measured by neuropsychological testing, and brain activity, as measured by electroencephalogram (EEG), while comparing different dTMS H-coils. Therefore, a second feature of the design includes assessing both domains over the course of treatment. The results will lay the foundation for a future randomized controlled trial examining the efficacy and mechanisms of one or both of these novel forms of neurostimulation for MDD in older adults.
Study Oversight
Has Oversight DMC:
False
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?: