RecruitingNot ApplicableNCT06112652

Neuromodulation of Different Doses to Treat TRD Guided by pBFS Technique

The Dosage Effect of Personalized Brain Functional Sectors(pBFS) Guided rTMS Treatment for Treatment-resistance Depression: a Randomized, Double-Blind, Sham-controlled Trial


Sponsor

Changping Laboratory

Enrollment

150 participants

Start Date

Dec 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether different doses of repetitive transcranial magnetic stimulation (rTMS — a non-invasive brain stimulation technique), guided by personalized brain mapping (pBFS), work better to treat treatment-resistant depression (depression that hasn't responded to multiple antidepressants). **You may be eligible if...** - You are between 18 and 65 years old with a confirmed diagnosis of major depression without psychotic symptoms - Your depression is currently severe (HAMD-17 score ≥ 20 and MADRS ≥ 20) - Your depression has not responded to at least two adequate antidepressant trials (moderate treatment resistance) - You have been on a stable antidepressant regimen (SSRIs or SNRIs) for at least 4 weeks **You may NOT be eligible if...** - You have a pacemaker, cochlear implant, or metal in your body, or claustrophobia - You have epilepsy or a history of seizures in the last 12 months - You have schizophrenia, bipolar disorder, or other serious psychiatric conditions - You have received ECT, prior rTMS, or other brain stimulation treatments in the last 3 months - You are pregnant or breastfeeding, or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE4 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.

DEVICE6 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.

DEVICE8 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.

DEVICE10 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.

DEVICEsham 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.


Locations(2)

Lei He

Zhumadian, Henan, China

Wuhan Mental Health Center

Wuhan, China

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NCT06112652


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