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

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.

Study Overview

• Status: Recruiting
• Conditions: Meige Syndrome
• Intervention / Treatment: Device: Bilateral STN deep brain stimulation; Device: Bilateral GPi deep brain stimulation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: chao zhang; Phone Number: 053182166631; Email: chao_zhang@sdu.edu.cn

Study Locations

• China
  • Sichuan
    • Jinan, Sichuan, China, 250100
      • Recruiting
      • Chao Zhang
      • Contact: chao zhang; Phone Number: +8613969007232; Email: chao_zhang@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Bilateral STN deep brain stimulation; Patients with Meige syndrome accepted STN DBS	Device: Bilateral STN deep brain stimulation; patients with Meige syndrome underwent bilateral subthalamic stimulation
Experimental: Bilateral GPi deep brain stimulation; Patients with Meige syndrome accepted GPi DBS	Device: Bilateral GPi deep brain stimulation; patients with Meige syndrome underwent bilateral pallidal stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: DBS; STN vs GPi
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Basal Ganglia Diseases; Movement Disorders; Dystonic Disorders; Syndrome; Meige Syndrome
• Other Study ID Numbers: STN or GPi in Meige Syndrom

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No