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

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 11

Maximum Age: 23

Healthy Volunteers: f

View:

• 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.

Locations

Other Locations

China

Deep Transcranial Magnetic Stimulation

RECRUITING

Taiyuan

Deep Transcranial Magnetic Stimulation

RECRUITING

Taiyuan

Contact Information

Primary

Zhifen Liu

zhifenliu@sxmu.edu.cn

+8613703586547

Time Frame

Start Date: 2024-12-31

Estimated Completion Date: 2026-06-30

Participants

Target number of participants: 100

Treatments

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.

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.

Related Therapeutic Areas

Major Depression

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