Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523439
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating a Truncated Version of SAINT in Treatment-Naive Adolescents With Depression An Open-Label Acceptability Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is a single-site open-label clinical trial of the Stanford Accelerated Intermittent Neuromodulation Therapy SAINT protocol The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation TMS-known generally as accelerated intermittent theta burst stimulation aiTBS and specifically as SAINT-is effective as a first-line therapy in treating adolescents aged 14-19 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial
The main questions this trial aims to answer are
Does SAINT relieve symptoms of depression as a first-line therapy in adolescents
Is SAINT a feasible option as a first-line treatment for adolescent depression
Researchers will measure the depression symptoms in adolescent participants before and after SAINT Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment
Adolescent participants will
Remain antidepressant-free throughout the study period of 6-7 weeks
Receive an MRI of their head for precision targeting
Receive 5 days of aiTBS SAINT
The main questions this trial aims to answer are
Does SAINT relieve symptoms of depression as a first-line therapy in adolescents
Is SAINT a feasible option as a first-line treatment for adolescent depression
Researchers will measure the depression symptoms in adolescent participants before and after SAINT Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment
Adolescent participants will
Remain antidepressant-free throughout the study period of 6-7 weeks
Receive an MRI of their head for precision targeting
Receive 5 days of aiTBS SAINT
Detailed Description:
This single-site open-label clinical trial aims to test the safety and efficacy of the Magnus Neuromodulation System MNS with Stanford Accelerated Intermittent Neuromodulation Therapy SAINT technology in treatment-naive adolescents with major depressive disorder MDD who remain antidepressant-free throughout the treatment The SAINT protocol or a truncated version 5 or 10 applications per day to a customized target within the left dorsolateral prefrontal cortex L-DLPFC identified with fMRI for five consecutive days in combination with MNS software will be delivered to each adolescent participant Changes in depressive symptoms will be measured at baseline and two follow up visits Additionally parents and adolescents will answer questions regarding their preference for SAINT as a first-line treatment option for MDD
The hypothesis is that adolescent participants receiving SAINT or the truncated version will demonstrate similar response and remission rates that are comparable to SAINT trials in adults 80-90 as measured by the Childhood Depression Rating Scale CDRS and Hamilton Depression Rating Scale
The primary objective of this study is to determine the efficacy of active SAINT in reducing symptoms of depression as measured by the CDRS at the one-month follow up time point
The study will enroll approximately 40 participants and employ a two-arm design with 20 participants per arm The target population is adolescents of all genders and ethnicities who are between 14 and 19 years of age with a diagnosis of MDD experiencing their first major depressive episode who have not received a full course of prior treatment 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 SAINT via a MagPro X100 edition MagVenture Skovlunde Denmark TMS device equipped with a Cool-B65 AP coil The stimulation paradigm consists of 5 or 10 daily sessions 25 or 50 total over 5-days of SAINT 3-pulse 50-Hz bursts at 5-Hz for 2-second trains with trains every 10 seconds guided by MNS 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
The hypothesis is that adolescent participants receiving SAINT or the truncated version will demonstrate similar response and remission rates that are comparable to SAINT trials in adults 80-90 as measured by the Childhood Depression Rating Scale CDRS and Hamilton Depression Rating Scale
The primary objective of this study is to determine the efficacy of active SAINT in reducing symptoms of depression as measured by the CDRS at the one-month follow up time point
The study will enroll approximately 40 participants and employ a two-arm design with 20 participants per arm The target population is adolescents of all genders and ethnicities who are between 14 and 19 years of age with a diagnosis of MDD experiencing their first major depressive episode who have not received a full course of prior treatment 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 SAINT via a MagPro X100 edition MagVenture Skovlunde Denmark TMS device equipped with a Cool-B65 AP coil The stimulation paradigm consists of 5 or 10 daily sessions 25 or 50 total over 5-days of SAINT 3-pulse 50-Hz bursts at 5-Hz for 2-second trains with trains every 10 seconds guided by MNS 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
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