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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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

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Meige Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Bilateral STN deep brain stimulation

Patients with Meige syndrome accepted STN DBS

Group Type PLACEBO_COMPARATOR

Bilateral STN deep brain stimulation

Intervention Type DEVICE

patients with Meige syndrome underwent bilateral subthalamic stimulation

Bilateral GPi deep brain stimulation

Patients with Meige syndrome accepted GPi DBS

Group Type EXPERIMENTAL

Bilateral GPi deep brain stimulation

Intervention Type DEVICE

patients with Meige syndrome underwent bilateral pallidal stimulation

Interventions

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Bilateral STN deep brain stimulation

patients with Meige syndrome underwent bilateral subthalamic stimulation

Intervention Type DEVICE

Bilateral GPi deep brain stimulation

patients with Meige syndrome underwent bilateral pallidal stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.