Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder

Efficacy and Safety of Deep Transcranial Magnetic Stimulation in Adolescent Major Depressive Disorder: a Prospective Double-Blind Randomized Controlled Trial

The goal of this randomized controlled trial is to explore the efficacy and safety of two different dTMS devices in adolescent depression: deep TMS H1 coil and deep TMS H7 coil.

The main questions it aims to answer are:

Type of study: Clinical trial. Participant population: Adolescents with major depressive disorder (MDD). Objective: To explore whether the H7 coil is no less effective than the H1 coil for adolescents with MDD, further providing clinicians with additional treatment options for patients.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Diorder
• Intervention / Treatment: Device: deep transcranial magnetic stimulation with H1coil; Device: deep transcranial magnetic stimulation with H7 coil

Detailed Description

Transcranial magnetic stimulation (TMS) is a safe and well-tolerated intervention that has been extensively studied as a treatment for MDD. However, little is known about the effectiveness of deep transcranial magnetic stimulation (dTMS) in adolescents with major depressive disorder (MDD). Only one open-label trial tested dTMS using H1 coils in adolescents with treatment-resistant depression, the results showed that the severity of depressive symptoms was significantly reduced after treatment, with a response rate of 42%. Hence, the continued efforts are needed to improve and optimize these treatments.

One important factor that influence the efficacy of TMS was the seletion of stimulation target. In recent years, medial prefrontal cortex (MPFC) and anterior cingulate cortex (ACC) have recently been considered promising alternative targets for treatment of adolescents with MDD, due to their association with reward, emotion, mood, and habits. Additionally, the stimulation target for dTMS with the H7 coil is the MPFC. Current relevant clinical studies show that after dTMS intervention using the H7 coil, depressive symptoms and overall clinical impressions in adults with MDD are significantly improved. However, whether alternative strategies for TMS treatment (e.g., H1 coil versus H7 coil) are more effective in adolescents with MDD remains unknown.

The purpose of this randomized controlled trial is to evaluate the efficacy and safety of two different dTMS devices (H1 coil and H7 coil) in the treatment of adolescent with MDD, further providing clinicians with additional treatment options for patients.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhifen Liu; Phone Number: +8613703586547; Email: zhifenliu@sxmu.edu.cn

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • Deep Transcranial Magnetic Stimulation
      • Contact: Zhifen Liu; Phone Number: 86+13703586547; Email: zhifenliu@sxmu.edu.cn
    • Taiyuan, Shanxi, China, 030012
      • Recruiting
      • Deep Transcranial Magnetic Stimulation
      • Contact: zhifen ZF Liu; Phone Number: +8613703586547; Email: zhifenliu@sxmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of all genders, aged between 11 and 23 years old, and right-handedness.
• In accordance with the diagnostic criteria for the major depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (M.I.N.I).
• Beck Depression Inventory, Second Edition (BDI-II): total BDI-II score> 13 at screening.
• Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.

Exclusion Criteria:

• A diagnosis of other psychiatric disorders in the DSM-5.
• Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the subject in completing the procedures required by the study.
• History of significant neurologic disease, including subdural hematoma, brain tumor, unexpected seizure/epilepsy disorder, or history of significant head trauma.
• Have obvious suicide risk, or have actual suicide behavior within 6 months before the screening.
• History of treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial Direct Current Stimulation (tDCS), or transcranial Alternating Current Stimulation (tACS) treatments for any disorders.
• There are contraindications to magnetic resonance imaging (MRI) scanning or TMS treatment, such as metal or electronic instruments.
• Participation in any investigational drug trial within 6 months before the baseline visit.
• Other conditions that are not suitable for the study object in the researcher's judgment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: H1 coil; First, the 'hot spot' for activation of the abductor pollicis brevis muscle was established and motor threshold (MT) determined. Then, the H1 coil was advanced 6 cm anterior to the scalp surface.The rMT was rechecked at least once a week. Treatment intensity was 80% of rMT.During 4 consecutive weeks (5 sessions/wk) patients were treated daily . Patients in the treatment group will receive the Deep TMS protocol (80% of rMT, 18 Hz, 2 seconds on and 20 seconds off over a 20-minute period; total of 1,980 stimuli per session), applied over the left dorsolateral prefrontal cortex.	Device: deep transcranial magnetic stimulation with H1coil; Participants will receive dTMS treatment with H1 coil
Experimental: H7 coil; First, the 'hot spot' for activation of the abductor pollicis brevis muscle was established and motor threshold (MT) determined. Then, the H7 coil was advanced 4 cm anterior to 'hot spot' and aligned symmetrically over the dmPFC. The rMT was rechecked at least once a week.The rMT was rechecked at least once a week. Treatment intensity was 80% of rMT.During 4 consecutive weeks (5 sessions/wk) patients were treated daily . Patients in the treatment group will receive the Deep TMS protocol (80% of rMT, 18 Hz, 2 seconds on and 20 seconds off over a 20-minute period; total of 1,980 stimuli per session), applied over themedial prefrontal cortex.	Device: deep transcranial magnetic stimulation with H7 coil; Participants will receive dTMS treatment with H7 coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response on Hamilton Depression Scale-24	Defined as a score reduction of 50% or more	From enrollment to the end of treatment at 12 weeks
Remission onHamilton Depression Scale-24	Defined as a score of 7 or less	From enrollment to the end of treatment at 12 weeks
Hamilton Depression Scale -24 (HAMD-24)	score change. Higher score means worse outcome.(Min = 0, Max = 76)	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Rating Scale (HAM-A)	score change. Higher score means worse outcome.(Min = 0, Max = 56)	From enrollment to the end of treatment at 12 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)	score change. Higher score means worse outcome.(Min= 0, Max = 56)	From enrollment to the end of treatment at 12 weeks
Beck Scale for Suicide Ideation-Chinese Version (BSI-CV)	score change. Higher score means worse outcome.(Min= 0, Max = 38)	From enrollment to the end of treatment at 12 weeks
Self-Injury Diary Card	Higher numeric value means worse outcome.	From enrollment to the end of treatment at 12 weeks
Pittsburgh sleep quality index(PSQI)	Higher score means worse outcome.(Min= 0, Max = 21)	From enrollment to the end of treatment at 12 weeks
Clinical Global Impression (CGI)	Higher score means worse outcome.(Min= 0, Max = 7)	From enrollment to the end of treatment at 12 weeks
Repeatable Battery for the Assessmental of Neuropsychological Status(RBANS)	Lower score means worse outcome.(Min=40, Max = 160)	From enrollment to the end of treatment at 12 weeks
Brief Symptom Inventory-18(BSI-18)	Higher score means worse outcome.(Min= 0, Max = 90)	From enrollment to the end of treatment at 12 weeks
Beck Depression Inventory-II	score change. Higher score means worse outcome.(Min= 0, Max = 63)	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Zhifen Liu

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: adolescents; deep transcranial magnetic stimulation; Major Depressive Diorder
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: NO.KYLL-2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No