Neuromodulation of Different Doses to Treat TRD Guided by pBFS Technique
NCT ID: NCT06112652
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-12-04
2025-12-30
Brief Summary
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Detailed Description
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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 1:1:1:1:1 ratio to each active rTMS group with different pulses (4×1800 pulses, 6×1800 pulses, 8×1800 pulses, 10×1800 pulses) and sham-control group. And then all participants will undergo a 5-day rTMS treatment followed by four- and eight weeks follow-up visits. Participants will keep a stable treatment regime during treatment and the four-week follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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4 session rTMS
Four sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.
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.
6 session rTMS
Six sessions of active TMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.
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.
8 session rTMS
Eight sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.
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.
10 session rTMS
Ten sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.
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.
sham rTMS
Subjects were randomized to receive 4 sessions or 6 sessions or 8 sessions or 10 sessions of sham rTMS to the left DLPFC daily in a 1:1:1:1 ratio.
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.
Interventions
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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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode.
* Total HAMD-17 score ≥20 and MADRS ≥20 before randomization.
* The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score ≥ 7 points).
* Participants currently are on stable drug use for at least 4 weeks before randomization. Antidepressants used are selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Combined use of two types of antidepressants is allowed.
* Voluntarily participate in the trial and able to provide informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.
Exclusion Criteria
* 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 plan 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.
18 Years
65 Years
ALL
No
Sponsors
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Wuhan Mental Health Centre
OTHER
Zhumadian Second People's Hospital
UNKNOWN
Changping Laboratory
OTHER
Responsible Party
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Principal Investigators
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Hesheng Liu, Ph.D.
Role: STUDY_CHAIR
Changping Laboratory
Locations
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Lei He
Zhumadian, Henan, China
Wuhan Mental Health Center
Wuhan, , China
Countries
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Central Contacts
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Facility Contacts
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He Lei
Role: primary
Aohan Bai, MD
Role: primary
Other Identifiers
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CPLMDDWHJW
Identifier Type: -
Identifier Source: org_study_id
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