pBFS Guided VS "5-cm Rule" rTMS Over DLPFC for MDD

NCT05964023 | Unknown

• 1 other identifier: CPLMDDDLV5cm
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

The investigators aim to investigate whether the intervention effect of pBFS-guided rTMS therapy targeting DLPFC is superior to the intervention effect of the traditional "5 cm-rule" guided rTMS therapy in patients with depressive disorders.

Conditions

Major Depression; MDD

Keywords

Major Depression, MDD; pBFS,; 5cm rule

Outcome Measures

Primary Outcomes (1)

• Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores

  The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).

  Baseline and Day 21

Secondary Outcomes (6)

• changes in MADRS

  Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment

• changes in HAMD

  Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment

• cognitive change in Digit Symbol Substitution Test (DSST)

  Baseline, Day 21 (Immediate Post-treatment)

• cognitive change in continuous performance test (CPT)

  Baseline, Day 21 (Immediate Post-treatment)

• cognitive change in Trail-Making Test (TMT)

  Baseline, Day 21 (Immediate Post-treatment)

Study Arms (2)

pBFS rTMS

EXPERIMENTAL

3 sessions of active rTMS would be delivered to the pBFS-guided left DLPFC daily, with a session of 1800 pulse.

Device: pBFS rTMS

5-cm rTMS

ACTIVE COMPARATOR

3 sessions of active rTMS would be delivered to the "5-cm rule" guided left DLPFC daily, with a session of 1800 pulse.

Device: 5-cm rTMS

Interventions

pBFS rTMS DEVICE

Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.

pBFS rTMS

5-cm rTMS DEVICE

Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be localized by "5-cm rule".

5-cm rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 recurrence episodes.
• Inpatients or outpatients aged 18-65 years (inclusive), male or female.
• Total HAMD-17 score ≥20 before randomization.Total MADRS score ≥25 before randomization.
• Inadequate response to at least one antidepressant trial of adequate doses and duration.
• Currently not taking any antidepressant medication. If previously medicated, a washout period of 7 days is required.
• Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.

You may not qualify if:

• 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 plans to become pregnant during the trial and the female 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.
• There is a significant risk of suicide (MADRS item 10 ≥ 5).
• 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.

Sponsors & Collaborators

• Changping Laboratory: lead

Study Sites (4)

Hebei Mental Health Center

Baoding, Hebei, China

RECRUITING

Henan Mental Hospital

Xinxiang, Henan, China

RECRUITING

Tianjin general hospital

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Hangzhou Seventh People's Hospital

Hanzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Hesheng Liu, Ph.D.

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Meiling Li, Ph.D.

CONTACT

010-80726688; meilingli@cpl.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 27, 2023
• Study Start: August 20, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2023-07

Locations

CN (4)