Neuromodulation of Different Doses to Treat TRD Guided by pBFS Technique

NCT06112652 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-06

No results posted yet for this study

Summary

The aim of this study is to explore the effectiveness and safety of different doses of neural regulation under the guidance of pBFS technology in improving symptoms in patients with moderate to severe depressive disorders.

Conditions

Interventions

DEVICE

4 session rTMS

Participants will receive 4 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

DEVICE

6 session rTMS

Participants will receive 6 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

DEVICE

8 session rTMS

Participants will receive 8 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

DEVICE

10 session rTMS

Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

DEVICE

sham rTMS

The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.

Sponsors & Collaborators

  • Wuhan Mental Health Centre

    collaborator OTHER
  • Changping Laboratory

    lead OTHER

Principal Investigators

  • Hesheng Liu, Ph.D. · Changping Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2026-12-20
Completion
2026-12-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112652 on ClinicalTrials.gov