NCT05964036

pBFS-guided High-dose TMS Over DMPFC for Treatment-resistant Major Depressive Disorder

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to evaluate the safety and efficacy of pBFS-guided DMPFC target and high-dose rTMS therapy for the treatment of patients with treatment-resistant depression

Detailed description

Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. Currently, the FDA cleared the SAINT Neuromodulation System for the treatment of Treatment-Resistant Depression(TRD) over the left dorsolateral prefrontal cortex (DLPFC). This methodology has been effective in a short period of time for treatment-resistant depression. However, some patients may not be able to persist in completing the treatment because they cannot bear the pain during treatment. The dorsomedial prefrontal cortex (DMPFC) region is relatively posterior, and DMPFC as an intervention target has been proven to have antidepressant effects, and patients have better pain tolerance during treatment, which can be used as an alternative to DLPFC target, so it is urgent to explore the effectiveness and safety of high-dose iTBS targeting DMPFC in the treatment of depression. 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 2:1 ratio to the active-rTMS group, and sham-rTMS group. Then all participants will undergo a 5-day rTMS modulation followed by two-week and four-week follow-up visits. Participants will keep a stable treatment regime during treatment and the four-week follow-up.

Conditions

• Depression
• Major Depressive Disorder
• Severe Depression

Interventions

Type	Name	Description
DEVICE	active TMS	Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized target in the DMPFC will be generated using the pBFS method
DEVICE	sham TMS	The parameters in the sham arm are the same as in the active stimulation group. Stimulation was delivered by the same device as the active group fitted with a sham coil

Timeline

• Start date: 2023-07-21
• Primary completion: 2024-04-20
• Completion: 2024-07-20
• First posted: 2023-07-27
• Last updated: 2024-02-07

Locations

1 site across 1 country: China