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

NCT06292559 | Unknown

• 1 other identifier: STN or GPi in Meige Syndrom
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Meige Syndrome

Keywords

DBS; STN vs GPi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• health-related quality of life

  12 months after DBS

• sleep quality status

  12 months after DBS

• Mental syndrome

  12 months after DBS

• Mental syndrome

  12 months after DBS

Study Arms (2)

Bilateral STN deep brain stimulation

PLACEBO COMPARATOR

Patients with Meige syndrome accepted STN DBS

Device: Bilateral STN deep brain stimulation

Bilateral GPi deep brain stimulation

EXPERIMENTAL

Patients with Meige syndrome accepted GPi DBS

Device: Bilateral GPi deep brain stimulation

Interventions

Bilateral STN deep brain stimulation DEVICE

patients with Meige syndrome underwent bilateral subthalamic stimulation

Bilateral STN deep brain stimulation

Bilateral GPi deep brain stimulation DEVICE

patients with Meige syndrome underwent bilateral pallidal stimulation

Bilateral GPi deep brain stimulation

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Meige syndrome was diagnosed by an experienced neurologist.
• 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.
• Tere were no other serious systemic diseases, such as severe organic heart disease, severe lung, liver and kidney dysfunction, and coagulation dysfunction.
• Tere was no history of neurological diseases other than Meige syndrome, such as Parkinson's disease or severe cognitive dysfunction.
• Tere were no serious psychiatric disorders, such as schizophrenia.
• Preoperative head magnetic resonance imaging (MRI) examinations were normal. Patients of missing follow-up and incomplete clinical data were excluded from the cases.

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Chao Zhang

Jinan, Shandong, 250100, China

RECRUITING

MeSH Terms

Conditions

Meige Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dystonic Disorders; Movement Disorders

Central Study Contacts

chao zhang

CONTACT

053182166631; chao_zhang@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 5, 2024
• Study Start: November 30, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: March 5, 2024

Record last verified: 2023-11

Locations

CN (1)