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

Major Depression Clinical Trial

Official title:

Personalized Brain Functional Sector-guided rTMS Therapy Targeting DLPFC VS "5-centimeter Rule" for Major Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964023
• Other study ID #: CPLMDDDLV5cm
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: July 2023
• Source: Changping Laboratory
• Contact: Meiling Li, Ph.D.
• Phone: 010-80726688
• Email: meilingli[@]cpl.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 blind manner in a 1:1 ratio to the pBFS group, or 5-cm rule group. Then all participants will undergo a 21-day rTMS modulation and 7-day, 14-day, and 45-day post-treatment follow-up visits. Participants will not take any other treatment during the intervention and the 7-day and 14-day post-treatment visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

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 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• MDD

Intervention

Device:
• pBFS rTMS
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.
• 5-cm rTMS
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".

Locations

Country	Name	City	State
China	Hebei Mental Health Center	Baoding	Hebei
China	Hangzhou Seventh People's Hospital	Hanzhou	Zhejiang
China	Tianjin general hospital	Tianjin	Tianjin
China	Henan Mental Hospital	Xinxiang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Changping Laboratory

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	changes in MADRS	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, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment
Secondary	changes in HAMD	The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items,and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity.	Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment
Secondary	cognitive change in Digit Symbol Substitution Test (DSST)	Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page	Baseline, Day 21 (Immediate Post-treatment)
Secondary	cognitive change in continuous performance test (CPT)	CPT from the C-BCT measures a person's sustained and selective attention	Baseline, Day 21 (Immediate Post-treatment)
Secondary	cognitive change in Trail-Making Test (TMT)	The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning	Baseline, Day 21 (Immediate Post-treatment)
Secondary	cognitive change in Digit Span Test (DST)	DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span	Baseline, Day 21 (Immediate Post-treatment)