Investigating a Truncated Version of SAINT in Treatment-Naive Adolescents With Depression: An Open-Label Acceptability Trial
University of Texas at Austin
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®)
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 adole…
Eligibility
- Age range
- 14–19 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or Female, between the ages of 14 and 19 at the time of screening. 2. Able to read, understand, and provide written, dated assent and/or consent prior to screening. Proficiency in English sufficient to complete questionnaires and follow instructions during aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information. 3. Diagnosed with Major Depressive Disorder (MDD) with a current Major Depress…
Interventions
- DeviceMagPro X100 edition (MagVenture, Skovlunde, Denmark)
10 daily sessions (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).
- DeviceMagPro X100 edition (MagVenture, Skovlunde, Denmark)
5 daily sessions (25 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).
Location
- Dell Medical School at University of Texas at AustinAustin, Texas