Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation

NCT07217444 | Recruiting DMC FDA Device

• 1 other identifier: 2025-0385
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the feasibility, safety, and preliminary efficacy of deep Transcranial Magnetic Stimulation (dTMS) as an adjunctive treatment for adolescents hospitalized with major depressive disorder (MDD).

Conditions

Major Depressive Disorder (MDD); Suicidal Ideation; Hospitalization in Children

Keywords

Major Depressive Disorder; MDD; Transcranial Magnetic Stimulation (TMS); Deep Transcranial Magnetic Stimulation; dTMS

Outcome Measures

Primary Outcomes (1)

• Tolerability and Safety

  We will collect and summarize descriptive data on discomfort and adverse events using Sections IV of the TMS Adverse Events and Associated Sensations Questionnaire (TMSens\_Q). This captures typical sensory experiences or side effects, e.g. scalp tingling or headache) as well as adverse events (e.g. syncope). Tolerability will be characterized based on sensory experiences and side effects, comparing active to sham treatment. Safety will be further assessed by the rate of early discontinuation due to intolerability or adverse events using the CCHMC Adverse Event form. Tolerability: Unit of measure: frequency and severity of sensory experiences and adverse events, e.g. scalp tingling or headache, syncope). Safety: Unit of measure: Rate of early discontinuation or withdrawal of treatment due to intolerability or adverse events.

  Completed before and immediately after the intervention

Secondary Outcomes (3)

• Hospitalization

  Completed monthly for the first 6 months, 9th and 12th month follow up

• Depression Symptoms

  Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up

• Suicide Risk

  Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up

Study Arms (2)

Active dTMS Treatment

ACTIVE COMPARATOR

Participants will receive active dTMS 5 sessions per day for 5 days

Device: Transcranial Magnetic Stimulation

Sham controlled

SHAM COMPARATOR

Sham dTMS 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12th month follow-up -reduction in depression symptoms from screening - they will then become eligible for and offered active, open-label treatment.

Device: Transcranial Magnetic Stimulation Sham

Interventions

Transcranial Magnetic Stimulation DEVICE

The Brainsway Deep TMS System with the FDA-cleared H7 Coil will be used to deliver all accelerated theta burst stimulation (aTBS) sessions. The H7 Coil is designed to target deeper and broader brain regions, including the prefrontal and anterior cingulate cortices, and has FDA 510(k) clearance for treatment of OCD and MDD in adults. Stimulation will follow a standardized accelerated theta burst protocol: triplet 50 Hz bursts delivered every 200 ms (5 Hz), in 2-second trains with 8 seconds off, at 90% RMT, totaling 600 pulses per session. Participants will receive five sessions per day over five business days with 30-minute breaks between the third and fourth sessions and exceeding or preceding these breaks will not be a protocol deviation. The sham coil mimics sensory experience without delivering stimulation.

Active dTMS Treatment

Transcranial Magnetic Stimulation Sham DEVICE

Investigators will use a robust sham technique that is manufacturer-designed to mimic the auditory and tactile sensations of active TMS without delivering effective magnetic stimulation to the brain. The Brainsway Sham H7-CoilTM will be utilized for treatment delivery. The H-7 coil already has a built-in sham system that can operate as a placebo. Only the TMS operators will have access to intervention assignments, the rest of the study team will not have access to assignments to maintain the blinded status of participants, caregivers, and raters.

Sham controlled

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
• Aged 14 years to 18 years, inclusive.
• Diagnosis of MDD based on psychologist diagnosis and DSM-5-checklist based interview.
• Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale Score \> 20.
• Participants are not required to discontinue current interventions

You may not qualify if:

• Participation in an investigational drug trial within the past three months.
• Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. ventriculoperitoneal shunt, pacemaker, medical pump).
• Actively psychotic (i.e. disorganized, delusional, paranoid, or having hallucinations)
• Actively suicidal (have a suicidal plan and intent and is on 1:1 close observation)
• For female subjects of childbearing potential, a positive urine pregnancy test.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45224, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Rana Elmaghraby, MD

  Cincinnati Childrens Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Krafft, Masters

CONTACT

5138038644; ashley.krafft@cchmc.org

Jennifer Combs, Masters

CONTACT

5138030007; jennifer.combs@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Model Details: It's a randomized sham-controlled trial with deep Transcranial Magnetic Stimulation (dTMS) treatment and sham controlled group

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 16, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the completion of data collection

Locations

US (1)