NCT05929183

Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

Efficacy and Safety Study of Neuronavigation Occipital rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years – 28 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the emotion-related brain area orbital frontal lobe (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute to further understand the relevant neural pathway and mechanism.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DEVICE	Repetitive Transcranial magnetic stimulation	Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of depressive symptom was dorsolateral prefrontal cortex (DLPFC). In this study, we use high frequency rTMS in the occipital lobe are precisely targeted by navigation, by stimulating the primary visual cortex（V1), can affect the orbitofrontal cortex (OFC), which is functionally connected to V1, and thus affect the entire nerve ring pathway excitability, thereby rapidly, effectively and safely improving mood symptoms in the acute phase of bipolar depressive episode. After the target was determined by fMRI navigation and positioning, the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.
DEVICE	Sham Repetitive Transcranial magnetic stimulation	The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters were the same as the Active Comparator arm.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-30
• Completion: 2023-07-01
• First posted: 2023-07-03
• Last updated: 2025-09-26

Locations

1 site across 1 country: China