NCT07021508

Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression

Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression: a Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to explore the efficacy and safety of temporal interference stimulation to improve bipolar depression, as well as to explore the corresponding neuroimaging mechanisms using magnetic resonance and electroencephalogram to provide novel intervention protocols and objective indicators of efficacy prediction for depressive episodes in bipolar disorder.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DEVICE	Temporal Interference Stimulation	A non-invasive, non-invasive method of deep brain electrical stimulation utilizing high-frequency electric field interactions to produce a low-frequency envelope to modulate neural activity.
DEVICE	Sham Temporal Interference Stimulation	The same machine was used as the temporal Interferenc real stimulus, with current creep only 20 seconds before stimulus onset to simulate the real stimulus sensation.

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-06-15
• Last updated: 2025-06-15

Locations

1 site across 1 country: China