Personalized Accelerated TMS for High-Risk Adolescent Depression
NCT ID: NCT07025720
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-07-01
2027-05-31
Brief Summary
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We want to see if:
1. This treatment is feasible and acceptable to patients
2. It can reduce depression and suicidal thoughts
3. It can lower the chance of going to the hospital
4. It affects daily functioning (school, work, relationships)
All participants will undergo 5-days of TMS treatment and complete MRI brain scans before and after treatment. They will return for check-ups after 1 week and 4 weeks.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TMS
TMS
The protocol involves delivering sessions of intermittent theta burst stimulation (iTBS) of 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation sessions will be delivered hourly. Ten sessions will be applied per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses in total). Stimulation will be delivered at 90% resting motor threshold (rMT) adjusted for cortical depth.
MR brain imaging will be used with the Localite Neuronavigation System (Localite GmbH, Sankt Augustin, Germany) to position the TMS coil over the individualized stimulation target.
Interventions
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TMS
The protocol involves delivering sessions of intermittent theta burst stimulation (iTBS) of 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation sessions will be delivered hourly. Ten sessions will be applied per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses in total). Stimulation will be delivered at 90% resting motor threshold (rMT) adjusted for cortical depth.
MR brain imaging will be used with the Localite Neuronavigation System (Localite GmbH, Sankt Augustin, Germany) to position the TMS coil over the individualized stimulation target.
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* age 15 years or older
* Discharged within the past week from the ED for chief complaint of SI OR recently admitted in urgent health care setting or seen in outpatient clinic for depression-related suicidal ideation
* Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)
Exclusion Criteria
* Use of benzodiazepines or medications that would interfere with TMS treatment as per PI discretion
* Active substance use or severe substance use that in the opinion of the PI would interfere with study participation
* Untreated, active psychosis
* Female patient who is breastfeeding, pregnant or who is planning a pregnancy during the study
* Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies
* Contraindications to receiving TMS and/or MRI as determined by screening questionnaires
15 Years
ALL
No
Sponsors
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Sorensen Foundation
UNKNOWN
University of California, Davis
OTHER
Responsible Party
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Locations
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UC Davis Medical Center
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Se Ri Bae, MD
Role: primary
Other Identifiers
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2227384
Identifier Type: -
Identifier Source: org_study_id