pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Depression

April 30, 2026 updated by: Changping Laboratory

Personalized Brain Functional Sectors (pBFS) Guided High-dose rTMS Therapy for Treatment-resistant Depression: A Randomized, Double-Blind, Sham-controlled Trial

We aim to evaluate the safety and efficacy of pBFS-guided high-dose rTMS therapy with short inter-session interval for patients with treatment-resistant depression

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. Currently, the FDA cleared the SAINT Neuromodulation System for the treatment of Treatment-Resistant Depression(TRD) over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in a short period of time for treatment-resistant depression. The limitation of this approach includes the long inter-session interval (~50min) of the treatment, patients need to wait about 8 hours for 10 session's intervention per day. Therefore, it is urgent to explore the efficacy and safety of rTMS with a short inter-session interval (e.g. 20 min) that is more acceptable for TRD patients.

After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1:1 ratio to the active short-interval rTMS group, active short-interval rTMS group, and active long-interval rTMS group. Then all participants will undergo a 5 day rTMS modulation followed by a four-week follow-up visit.

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 Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100096
        • Beijing HuiLongGuan Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
  • Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for the depression disorder without psychotic symptoms, and currently experiencing the first episode or recurrence episode.
  • Total HAMD17 score ≥18 before randomization.
  • Total MADRS score ≥20 before randomization.
  • A stable or no-drug use for at least 4 weeks before randomization. The type and dose of the antidepressant regimen remained unchanged throughout the study.
  • No response (symptom improvement≥50%) in previous treatments with at least two antidepressants for a full dose and full course.
  • Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.

Exclusion Criteria:

  • Meet DSM-5 diagnostic criteria for other mental disorders (e.g., schizophrenia spectrum disorders, bipolar and related disorders, anxiety disorders, compulsion, and related disorders, trauma and stress-related disorders, etc.), or secondary depression;
  • Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;
  • Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher;
  • History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold;
  • History of ECT, rTMS, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months;
  • Currently receiving or planning to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial.
  • Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year;
  • Female of childbearing potential who plans to become pregnant during the trial.
  • Female that is pregnant or breastfeeding.
  • Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening.
  • Investigators think that was inappropriate to participate.

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
Experimental: Active rTMS with short inter-session interval
Patients in this group will receive rTMS intervention with short inter-session intervals.
Device: Active rTMS with short inter-session interval
Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 20 min for 5 days. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.
Sham Comparator: Sham rTMS with short inter-session interval
Patients in this group will receive sham rTMS intervention with short inter-session intervals.
Device: Sham rTMS with short inter-session interval
Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 20 min for 5 days, using sham stimulation coils that comprehensively mimic the active condition. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.
Active Comparator: Active rTMS with long inter-session interval
Patients in this group will receive rTMS intervention with long inter-session intervals.
Device: Active rTMS with long inter-session interval
Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 50 min for 5 days. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 4 weeks post-treatment
Time Frame: Baseline, 28 days post-treatment
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher scores represent higher depression severity. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).
Baseline, 28 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission and response rates estimated using MADRS, HAMD, QIDS_SR
Time Frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Three questionnaires were used to assess the response rate and remission rate of depression separately. Response is defined as an symptom improvement ≥50% on these scales; remission was defined as a score< 11 on MADRS, or <8 on HAMD, or <6 on QIDS_SR.
Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Safety measures using SSI and YMRS
Time Frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Scale for Suicide Ideation (SSI) and Young Mania Rating Scale (YMRS) were used to estimated suicide ideation and manic symptoms
Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment
Change in MADRS, HAMD-17, and QIDS_SR from baseline to different time points
Time Frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment
Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment

Collaborators and Investigators

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

Sponsor

Changping Laboratory

Collaborators

Beijing HuiLongGuan Hospital

Investigators

  • Study Chair: Hesheng Liu, Ph.D., Changping Laboratory

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)

June 19, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPLMDDhlg2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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