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
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
- Moderate Depression
- Major Depressive Disorder
- Severe Depression
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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