Recruiting

dTMS

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07217444

Conditions

Major Depressive Disorder (MDD)

Suicidal Ideation

Hospitalization in Children

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation Sham

Study Details

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

Study ID

NCT07217444

Start date

Nov 13, 2025

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. Aged 14 years to 18 years, inclusive.
3. Diagnosis of MDD based on psychologist diagnosis and DSM-5-checklist based interview.
4. Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale Score > 20.
5. Participants are not required to discontinue current interventions

Exclusion Criteria:

1. Participation in an investigational drug trial within the past three months.
2. 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).
3. Actively psychotic (i.e. disorganized, delusional, paranoid, or having hallucinations)
4. Actively suicidal (have a suicidal plan and intent and is on 1:1 close observation)
5. For female subjects of childbearing potential, a positive urine pregnancy test.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active dTMS Treatment

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

sham comparator: Sham controlled

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.

Interventions

Transcranial Magnetic Stimulation

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.

Transcranial Magnetic Stimulation Sham

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.

Primary outcome measure

  • Tolerability and Safety [ Time Frame: Completed before and immediately after the intervention ]

Central Contacts and Locations

Central contacts

Ashley Krafft, Masters

5138038644ashley.krafft@cchmc.org

Jennifer Combs, Masters

5138030007jennifer.combs@cchmc.org

Locations

Cincinnati Childrens Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45224

Contacts

Ashley Krafft, Masters

5138038644ashley.krafft@cchmc.org

Jennifer Combs, Masters

5138030007jennifer.combs@cchmc.org

Principal Investigator:

Rana Elmaghraby, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-02-11.