Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462820
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
SAINT for MDD in an Inpatient Setting Follow-on
Sponsor:
Magnus Medical
Organization:
Magnus Medical
Study Overview
Official Title:
SAINT Neuromodulation System for the Treatment of Depression in an Inpatient Setting
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Randomized multi-site sham-controlled double-blinded study
Detailed Description:
This multi-site double-blind randomized sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System MNS with Stanford Accelerated Intermittent Neuromodulation Therapy SAINT Technology for the treatment of depression and suicidal cognitions in psychiatrically hospitalized patients with Major Depressive Disorder MDD and active suicidal ideation SI This will be accomplished by applying the MNS with SAINT protocol 10 applications per day to a customized target within the left dorsolateral prefrontal cortex L-DLPFC identified with fMRI for five consecutive days and measuring changes in depressive symptoms and suicidality at baseline and immediate-post visit
Th clinical hypothesis is that participants receiving per-protocol active SAINT stimulation will demonstrate a significant difference in Montgomery-Asberg Depression Rating Scale MADRS scoresremission rates at the immediate post treatment visit compared to those who receive per protocol sham SAINT stimulation
The primary objective of this study is to determine the efficacy of active SAINT vs sham SAINT in reducing symptoms of depression as measured by the MADRS
The study will enroll approximately 100 participants and employ a two-arm design with 50 subjects per arm The target population is adults of all genders and ethnicities who are between 18 and 75 years of age with a diagnosis of treatment-resistant MDD experiencing a current Major Depressive Episode with active suicidal ideation and who are otherwise in good general health Participants must be without contraindications to Magnetic Resonance Imaging MRI or transcranial magnetic stimulation TMS and must be able to attend all study visits
This study will deliver both active and sham SAINT via a MagPro X100 edition MagVenture Skovlunde Denmark TMS device equipped with a Cool-B65 AP coil The stimulation paradigm consists of 10 daily sessions 50 total over 5-days of MNS with SAINT stimulation 3-pulse 50-Hz bursts at 5-Hz for 2-second trains with trains every 10 seconds delivered with 50-minute inter-session intervals 10-minute sessions 50-minutes in between sessions Stimulation will be delivered at 90 of the resting motor threshold with depth correction to account for the distance between the scalp and cortex An operator entered code derived from the study EDC will instruct the device to deliver active or sham magnetic stimulation
Th clinical hypothesis is that participants receiving per-protocol active SAINT stimulation will demonstrate a significant difference in Montgomery-Asberg Depression Rating Scale MADRS scoresremission rates at the immediate post treatment visit compared to those who receive per protocol sham SAINT stimulation
The primary objective of this study is to determine the efficacy of active SAINT vs sham SAINT in reducing symptoms of depression as measured by the MADRS
The study will enroll approximately 100 participants and employ a two-arm design with 50 subjects per arm The target population is adults of all genders and ethnicities who are between 18 and 75 years of age with a diagnosis of treatment-resistant MDD experiencing a current Major Depressive Episode with active suicidal ideation and who are otherwise in good general health Participants must be without contraindications to Magnetic Resonance Imaging MRI or transcranial magnetic stimulation TMS and must be able to attend all study visits
This study will deliver both active and sham SAINT via a MagPro X100 edition MagVenture Skovlunde Denmark TMS device equipped with a Cool-B65 AP coil The stimulation paradigm consists of 10 daily sessions 50 total over 5-days of MNS with SAINT stimulation 3-pulse 50-Hz bursts at 5-Hz for 2-second trains with trains every 10 seconds delivered with 50-minute inter-session intervals 10-minute sessions 50-minutes in between sessions Stimulation will be delivered at 90 of the resting motor threshold with depth correction to account for the distance between the scalp and cortex An operator entered code derived from the study EDC will instruct the device to deliver active or sham magnetic stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None