Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
NCT ID: NCT07217444
Last Updated: 2026-02-11
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-11-13
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transcranial Magnetic Stimulation for Adolescent Depression
NCT01731678
Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder
NCT05652465
rTMS for Youth Inpatients With Depression
NCT07140575
Efficacy and Safety of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study
NCT07185438
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
NCT01502033
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active dTMS Treatment
Participants will receive active dTMS 5 sessions per day for 5 days
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
14 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rana Elmaghraby
ASSISTANT PROFESSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rana Elmaghraby, MD
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Childrens Hospital Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-0385
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.