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

Not Applicable

Recruiting

• Conditions: Meige Syndrome
• Interventions: Device: Bilateral STN deep brain stimulation; Device: Bilateral GPi deep brain stimulation

• Registration Number: NCT06292559
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-30
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Primary Meige syndrome was diagnosed by an experienced neurologist.
2. All patients had received systematic and regular treatment for at least 1 year before surgery, including oral drugs and local injection of botulinum toxin A, but the efficacy was not apparent, as the ability to engage with daily life and the quality of life of the patients significantly decreased.
3. Tere were no other serious systemic diseases, such as severe organic heart disease, severe lung, liver and kidney dysfunction, and coagulation dysfunction.
4. Tere was no history of neurological diseases other than Meige syndrome, such as Parkinson's disease or severe cognitive dysfunction.
5. Tere were no serious psychiatric disorders, such as schizophrenia.
6. Preoperative head magnetic resonance imaging (MRI) examinations were normal. Patients of missing follow-up and incomplete clinical data were excluded from the cases.

Exclusion Criteria

1. Unilateral facial spas and blepharospasm.
2. Patients with severe disease such as coronary heart disease, stroke.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral STN deep brain stimulation	Bilateral STN deep brain stimulation	Patients with Meige syndrome accepted STN DBS
Bilateral GPi deep brain stimulation	Bilateral GPi deep brain stimulation	Patients with Meige syndrome accepted GPi DBS

Primary Outcome Measures

Name	Time	Method
Change in motor function	12 months after DBS	The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M)at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery.

Secondary Outcome Measures

Name	Time	Method
health-related quality of life	12 months after DBS	Secondary outcomes included health-related quality of life (EuroQol Five Dimensions Questionnaire) at 3 days before and 12 months after DBS surgery.
sleep quality status	12 months after DBS	Secondary outcomes included sleep quality status (Pittsburgh Sleep Quality Index) at 3 days before and 12 months after DBS surgery.
Mental syndrome	12 months after DBS	Secondary outcomes included depression severity, and anxiety severity including Hamilton Anxiety Scale (HAMA) scores at 3 days before and 12 months after DBS surgery.

Trial Locations

Locations (1)

Chao Zhang; 🇨🇳 Jinan, Sichuan, China