Major Depressive Disorder (MDD)IMPACT-DNCT07217444
Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder (MDD) and Suicidal Ideation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Suicidal Ideation, Hospitalization in Children
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45224
Ashley Krafft, Masters, 5138038644, ashley.krafft@cchmc.org
Jennifer Combs, Masters, 5138030007, jennifer.combs@cchmc.org
About this study
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).
Read the detailed description
The overall goal of this study is to 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). Our central hypotheses are that dTMS H7 targeting the dorsomedial prefrontal and cingulate cortices, delivered via the Brainsway H7-Coil™, will be safe, well tolerated, and lead to improved depressive symptoms, reduced suicide risk, and lower readmission rates compared to sham treatment. Investigators propose a double-blind, sham-controlled randomized clinical trial enrolling 14- to 18-year-old inpatients with MDD with or without obsessive compulsive disorder (OCD). Participants (n=60) will be randomized to receive either active or sham TMS during hospitalization, with follow-up assessments continuing for 12 months post-discharge. Outcomes will include safety, tolerability, treatment adherence, depressive symptom change, suicidal ideation, and time to psychiatric readmission. This study will provide foundational data to support the clinical integration of TMS into inpatient care for adolescents with treatment-resistant depression.
- Being tested
- Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Sham
- Keywords
- Major Depressive Disorder, MDD, Transcranial Magnetic Stimulation (TMS), Deep Transcranial Magnetic Stimulation, dTMS
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
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 ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active dTMS Treatment | Active comparator | Participants will receive active dTMS 5 sessions per day for 5 days Receives: 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. Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Completed before and immediately after the intervention
Secondary outcomes (3)
Hospitalization
Time to first psychiatric readmission or emergency department (ED) visit for depression or suicidality within 12 months post-discharge.
Unit of Measure: Time to first psychiatric readmission or ED visit (months).
Measured: Completed monthly for the first 6 months, 9th and 12th month follow up
Depression Symptoms
Change in depressive symptom severity as rated by the Hamilton Depression Rating Scale (HDRS-17). The HDRS is a 17-item rating scale administered by a trained rater following a semi-structured interview. Scores of 0-7 are generally within the normal range, and a score of 20 or higher indicates moderate depression severity. Research suggests that a decrement of 7 points on the HAMD-17 represents minimally clinically important differences from patient perspectives.
Unit of Measure:
HDRS-17 total score.
Measured: Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up
Suicide Risk
Change in suicidal ideation and behavior from screening to follow-up, assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Unit of Measure:
C-SSRS severity.
Measured: Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start13 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's a randomized sham-controlled trial with deep Transcranial Magnetic Stimulation (dTMS) treatment and sham controlled group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elmaghraby, Children's Hospital Medical Center, Cincinnati
- Investigators
- Rana Elmaghraby, MD, Principal investigator, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217444
- Sponsor's protocol ID
- 2025-0385
- Acronym
- IMPACT-D
- Status last verified
- Feb 2026
- First submitted
- 8 Oct 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All the IPD collected throughout this trial
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT07217444
- Acronym / sponsor ID
- IMPACT-D / 2025-0385
- Keywords
- Major Depressive Disorder, MDD, Transcranial Magnetic Stimulation (TMS), Deep Transcranial Magnetic Stimulation, dTMS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The overall goal of this study is to 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). Our central hypotheses are that dTMS H7 targeting the dorsomedial prefrontal and cingulate cortices, delivered via the Brainsway H7-Coil™, will be safe, well tolerated, and lead to improved depressive symptoms, reduced suicide risk, and lower readmission rates compared to sham treatment. Investigators propose a double-blind, sham-controlled randomized clinical trial enrolling 14- to 18-year-old inpatients with MDD with or without obsessive compulsive disorder (OCD). Participants (n=60) will be randomized to receive either active or sham TMS during hospitalization, with follow-up assessments continuing for 12 months post-discharge. Outcomes will include safety, tolerability, treatment adherence, depressive symptom change, suicidal ideation, and time to psychiatric readmission. This study will provide foundational data to support the clinical integration of TMS into inpatient care for adolescents with treatment-resistant depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It's a randomized sham-controlled trial with deep Transcranial Magnetic Stimulation (dTMS) treatment and sham controlled group
| Arm | Type | Receives |
|---|---|---|
| Active dTMS Treatment | Active comparator | Device: Transcranial Magnetic StimulationParticipants will receive active dTMS 5 sessions per day for 5 days |
| Sham controlled | Sham comparator | Device: Transcranial Magnetic Stimulation ShamSham 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationThe 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. | Device | Active dTMS Treatment |
| Transcranial Magnetic Stimulation ShamInvestigators 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. | Device | Sham controlled |
Primary outcome
Tolerability and Safety
Time frame: Completed before and immediately after the intervention
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.
3 secondary outcomes
Hospitalization
Time frame: Completed monthly for the first 6 months, 9th and 12th month follow up
Depression Symptoms
Time frame: Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up
Suicide Risk
Time frame: Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Yes. All the IPD collected throughout this trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rana Elmaghraby, MD principal investigator
Cincinnati Childrens Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder (MDD) and Suicidal Ideation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Krafft, Masters (5138038644, ashley.krafft@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability and Safety (time frame: Completed before and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.