NCT05957341

pBFS Guided 20min Inter-session Interval rTMS Treatment for MDD

Personalized Brain Functional Sectors(pBFS) Guided 20min Inter-session Interval rTMS Treatment for Major Depressive Disorder： a Randomized， Double-Blind， Sham-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating patients with moderate to severe depression.

Detailed description

FDA-approved intermittent theta burst stimulation (iTBS) for the treatment of depression disorder, reduces the duration of a single sequence treatment from 37 minutes to 3 minutes with traditional rTMS and gets the same antidepressant effect. Studies have shown that large doses and individualized target stimulation based on iTBS can improve the efficacy of rTMS and greatly save the time spent during patient treatment, but the effect of the interval between iTBS sessions on the efficacy is inconclusive. Previous studies on interval effect in rats based on iTBS have indirectly found that the waiting time between iTBS sessions of 50 to 90 minutes can maximize the cumulative effect of stimulation, so researchers mostly set the iTBS treatment interval to 50 minutes. However, most patients give up treatment because of the long wait time of 50 minutes, so it is urgent to explore the effect of short intervals of iTBS accepted easier by patients. In this study, we examined the intersession interval of 50 min vs. 20 min in the efficacy and safety of pBFS-guided TMS treatment in patients with moderate to severe 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 double-blind manner in a 4:4:1:1 ratio to a 50-minute active rTMS group, a 20-minute active rTMS group, a 50-minute sham-control group, and a 20-minute sham-control group. And then all participants will undergo a 21-day rTMS treatment followed by two-week and four-week follow-up visits.

Conditions

• Moderate Depression
• Major Depressive Disorder
• Severe Depression

Interventions

Type	Name	Description
DEVICE	active rTMS: 20min inter-session interval	Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 20 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.
DEVICE	active rTMS: 50min inter-session interval	Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 50 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.
DEVICE	sham rTMS: 20min inter-session interval	The parameters in this group are the same as in the active rTMS: 20min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.
DEVICE	sham rTMS: 50min inter-session interval	The parameters in this group are the same as in the active rTMS: 50min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.

Timeline

• Start date: 2023-07-30
• Primary completion: 2024-07-30
• Completion: 2024-08-30
• First posted: 2023-07-24
• Last updated: 2023-07-24