High-dose TMS treatment for severe depression using a new targeting method

Personalized Brain Functional Sectors (pBFS)-Guided DMPFC With High-dose rTMS for Treatment-resistant Depressive Disorder: a Randomized, Double-blind, Sham-controlled Trial

This study is testing a new way of using high-dose brain stimulation to see if it can help people with severe depression who haven't found relief from other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Changping Laboratory (other)
• Locations: 1 site (Baoding, Hebei)
• Trial ID: NCT05964036 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of high-dose repetitive transcranial magnetic stimulation (rTMS) guided by precision targeting of the dorsomedial prefrontal cortex (DMPFC) for patients with treatment-resistant major depressive disorder. Participants will be randomly assigned to receive either active rTMS or sham treatment over a 5-day period, followed by follow-up visits at two and four weeks. The study aims to determine if targeting the DMPFC can improve treatment outcomes while minimizing discomfort compared to traditional methods. All participants will be screened for eligibility based on specific diagnostic criteria and treatment history.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of recurrent depressive disorder who have not responded adequately to previous antidepressant treatments.

Not a fit: Patients with other mental disorders, certain medical implants, or contraindications to rTMS may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and tolerable treatment option for patients suffering from treatment-resistant depression.

How similar studies have performed: While rTMS has been established as a treatment for depression, this specific targeting method is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* DSM-5 diagnosis of depressive disorder, recurrent episodes;
* A total score of at least 20 on the HAMD-17 and Montgomery-Asberg Depression Rating Scale;
* Aged 18-65 years, female or male;
* Inadequate response to at least one antidepressant trial of adequate doses and duration;
* The MSM (Maudsley Staging Method) score ≥ 7;
* Stable antidepressant regimen for at least 4 weeks before treatment;
* Understand the trial and sign the informed consent.

Exclusion Criteria:

* Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.);
* 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;
* The female of childbearing potential who plans to become pregnant during the trial, and that is pregnant or breastfeeding.
* Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening.
* First-degree relatives have bipolar affective disorder.
* Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators.
* Investigators think that was inappropriate to participate.

Where this trial is running

Baoding, Hebei

• Hebei Mental Health Center — Baoding, Hebei, China (RECRUITING)

Study contacts

• Study coordinator: Meiling Li, phd

Conditions: Depression, Major Depressive Disorder, Severe Depression, transcranial magnetic stimulation, rTMS, DMPFC, pBFS, precision target