RecruitingNot ApplicableNCT04502758

Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder

Sponsor

Mayo Clinic

Enrollment

80 participants

Start Date

Apr 4, 2022

Study Type

INTERVENTIONAL

Conditions

Suicidal Ideation Major Depressive Disorder

Summary

The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.

Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of non-invasive brain stimulation called theta burst stimulation (TBS) — delivered using a device placed on the scalp — to reduce suicidal thoughts in teenagers with depression who are receiving inpatient or outpatient mental health care. **You may be eligible if...** - You are between 12 and 18 years old - You have been diagnosed with major depressive disorder (MDD) - You are currently experiencing suicidal thoughts - A parent or legal guardian can provide consent on your behalf **You may NOT be eligible if...** - You have a metal implant in your head (such as a pacemaker or cochlear implant) - You have a history of seizures or epilepsy - You have been diagnosed with bipolar disorder or psychosis - You are currently pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagVenture TMS Therapy System w/Theta Burst Stimulation

During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field properties on the active site are identical to that of the standard Cool-B70 coil, cleared for iTBS treatment.

DEVICESham MagVenture TMS Therapy System w/Theta Burst Stimulation

During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field on the sham site is significantly reduced, and is less than 5% of that of the active site.