NCT06292559

A Comparison Between STN-DBS and GPi-DBS in Meige Syndrome Evaluated by Flexible Electrodes

A Randomized Prospective Study Between STN-DBS and GPi-DBS in Meige Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Researchers designed this study to compare the 12-month outcomes for patients who undergo bilateral stimulation of the GPi or STN.

Detailed description

Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are accepted targets for this treatment. Researchers are willing to compared12-month outcomes for patients who had undergone bilateral stimulation of the GPi or STN. Forty-two Asian patients with primary Meige syndrome who underwent GPi or STN neurostimulation were recruited between Nov. 2023 and Nov. 2025 at the Department of Neurosurgery, Qilu Hospital. The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M) and disability subscale (BFMDRS-D) at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery. Secondary outcomes included health-related quality of life, sleep quality status, depression severity, and anxiety severity at 3 days before and 12 months after DBS surgery.

Conditions

• Meige Syndrome

Interventions

Type	Name	Description
DEVICE	Bilateral STN deep brain stimulation	patients with Meige syndrome underwent bilateral subthalamic stimulation
DEVICE	Bilateral GPi deep brain stimulation	patients with Meige syndrome underwent bilateral pallidal stimulation

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-11-30
• Completion: 2025-11-30
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: China