Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation (IMPACT-D)

February 10, 2026 updated by: Rana Elmaghraby, Children's Hospital Medical Center, Cincinnati
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • Recruiting
        • Cincinnati Childrens Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Rana Elmaghraby, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active dTMS Treatment
Participants will receive active dTMS 5 sessions per day for 5 days
Device: 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 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Completed before and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: Completed monthly for the first 6 months, 9th and 12th month follow up

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).
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

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.
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Rana Elmaghraby, MD, Cincinnati Childrens Hospital Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

October 8, 2025

First Submitted That Met QC Criteria

October 14, 2025

First Posted (Actual)

October 16, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the IPD collected throughout this trial

IPD Sharing Time Frame

After the completion of data collection

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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