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

Meige Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292559
• Other study ID #: STN or GPi in Meige Syndrom
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Qilu Hospital of Shandong University
• Contact: chao zhang
• Phone: 053182166631
• Email: chao_zhang[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meige Syndrome
• Syndrome

Intervention

Device:
• Bilateral STN deep brain stimulation
patients with Meige syndrome underwent bilateral subthalamic stimulation
• Bilateral GPi deep brain stimulation
patients with Meige syndrome underwent bilateral pallidal stimulation

Locations

Country	Name	City	State
China	Chao Zhang	Jinan	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in motor function	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.	12 months after DBS
Secondary	health-related quality of life	Secondary outcomes included health-related quality of life (EuroQol Five Dimensions Questionnaire) at 3 days before and 12 months after DBS surgery.	12 months after DBS
Secondary	sleep quality status	Secondary outcomes included sleep quality status (Pittsburgh Sleep Quality Index) at 3 days before and 12 months after DBS surgery.	12 months after DBS
Secondary	Mental syndrome	Secondary outcomes included depression severity, and anxiety severity including Hamilton Depression Scale (HAMD) scores at 3 days before and 12 months after DBS surgery.	12 months after DBS
Secondary	Mental syndrome	Secondary outcomes included depression severity, and anxiety severity including Hamilton Anxiety Scale (HAMA) scores at 3 days before and 12 months after DBS surgery.	12 months after DBS