NCT05842291

pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Depression

Personalized Brain Functional Sectors (pBFS) Guided High-dose rTMS Therapy for Treatment-resistant Depression: A Randomized, Double-Blind, Sham-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

We aim to evaluate the safety and efficacy of pBFS-guided high-dose rTMS therapy with short inter-session interval for 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 (L-DLPFC). This methodology has been effective in a short period of time for treatment-resistant depression. The limitation of this approach includes the long inter-session interval (\~50min) of the treatment, patients need to wait about 8 hours for 10 session's intervention per day. Therefore, it is urgent to explore the efficacy and safety of rTMS with a short inter-session interval (e.g. 20 min) that is more acceptable for TRD patients. 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 ratio to the active short-interval rTMS group, active short-interval rTMS group, and active long-interval rTMS group. Then all participants will undergo a 5 day rTMS modulation followed by a four-week follow-up visit.

Conditions

• Treatment-Resistant Depression

Interventions

Type	Name	Description
DEVICE	Active rTMS with short inter-session interval	Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 20 min for 5 days. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.
DEVICE	Sham rTMS with short inter-session interval	Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 20 min for 5 days, using sham stimulation coils that comprehensively mimic the active condition. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.
DEVICE	Active rTMS with long inter-session interval	Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 50 min for 5 days. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.

Timeline

• Start date: 2023-06-19
• Primary completion: 2024-08-01
• Completion: 2024-11-01
• First posted: 2023-05-06
• Last updated: 2023-07-03

Locations

1 site across 1 country: China