Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

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®)

Conditions

• Major Depressive Disorder
• Depression in Adolescence
• Depression
• Major Depressive Episode

Interventions

DEVICE

MagPro 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).

DEVICE

MagPro 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).

Sponsors & Collaborators

• Magnus Medical

  collaborator INDUSTRY

• University of Texas at Austin

  lead OTHER

Principal Investigators

• Sean J O'Sullivan, M.D., Ph. D. · University of Texas at Austin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2026-09-30

Completion

2026-09-30

FDA Device

Yes

Countries

• United States

Study Locations