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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06292559
Enrollment
100
Registered
2024-03-05
Start date
2023-11-30
Completion date
2025-11-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meige Syndrome

Keywords

DBS, STN vs GPi

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.

Interventions

patients with Meige syndrome underwent bilateral subthalamic stimulation

patients with Meige syndrome underwent bilateral pallidal stimulation

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in motor function12 months after DBSThe 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

MeasureTime frameDescription
health-related quality of life12 months after DBSSecondary outcomes included health-related quality of life (EuroQol Five Dimensions Questionnaire) at 3 days before and 12 months after DBS surgery.
sleep quality status12 months after DBSSecondary outcomes included sleep quality status (Pittsburgh Sleep Quality Index) at 3 days before and 12 months after DBS surgery.
Mental syndrome12 months after DBSSecondary outcomes included depression severity, and anxiety severity including Hamilton Depression Scale (HAMD) scores at 3 days before and 12 months after DBS surgery.

Countries

China

Contacts

Primary Contactchao zhang
chao_zhang@sdu.edu.cn053182166631

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026