NCT06166082

Stanford Neuromodulation Therapy (SNT) for the Treatment-Resistant Depression

Stanford Neuromodulation Therapy (SNT) for the Treatment-Resistant Depression: A Study Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, and sham-controlled trial using the identical protocol as the SNT to replicate the antidepressant efficacy of SNT for TRD. Patients will be recruited and randomly assigned (1:1 ratio) to receive active or sham groups from 5 hospitals in China. The interventions will last for 5 days and both groups will be followed up for 8 weeks on the same time schedules. During the intervention and at least the first 4 weeks of post-treatment, participants will keep a stable antidepressant regimen. The individualized SNT target in the left dorsolateral prefrontal cortex (DLPFC) will be generated from 30 minutes of resting-state functional MRI collected at baseline.

Detailed description

Repetitive Transcranial Magnetic Training (rTMS) is a non-invasive neuromodulation that has been approved by the Food and Drug Administration (FDA) for treating patients with treatment-resistant depression(TRD). In 2022, the US FDA approved a high-dose intervention called Stanford Neuromodulation Therapy (SNT) to achieve rapid relief of patient symptoms in TRD. This therapy involves 10 1800 pulse Intermittent Theta Burst Stimulation (iTBS) interventions per day for consecutive 5 days on the dorsolateral prefrontal cortex (DLPFC), with 50 minutes inter-session intervals. At the end of the SNT intervention, the response rate reached 71.4% (13.3% in the sham group); At the 4th week follow-up after treatment, the response rate was 69.2% (7.1% in the sham group). This therapy has the advantage of quickly taking effect in the treatment of patients with TRD in a short period. However, there are also some limitations with this therapy, such as the need to undergo 10 high-dose interventions with 1800 pulses per day, which takes about 9 hours and may reduce patient compliance with the treatment. In addition, this study is a single-center small sample trial (14 cases with active and 15 cases with sham stimulation). The SNT therapy brings confidence to TRD patients, its efficacy and safety need to be verified in multicenter, randomized, double-blind, placebo-parallel controlled clinical trials.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DEVICE	Active iTBS-DLPFC	Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days.
DEVICE	Sham iTBS-DLPFC	The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.

Timeline

• Start date: 2023-12-22
• Primary completion: 2024-07-31
• Completion: 2024-10-31
• First posted: 2023-12-12
• Last updated: 2024-02-06

Locations

5 sites across 1 country: China