Clinical trial NCT06292559: A Comparison Between STN-DBS and GPi-DBS in Meige Syndrome Evaluated by Flexible Electrodes
Official title: A Randomized Prospective Study Between STN-DBS and GPi-DBS in Meige Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meige Syndrome
Keywords: DBS
STN vs GPi
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in motor function
timeFrame: 12 months after DBS
Secondary outcomes:
measure: health-related quality of life
timeFrame: 12 months after DBS
measure: sleep quality status
timeFrame: 12 months after DBS
measure: Mental syndrome
timeFrame: 12 months after DBS
measure: Mental syndrome
timeFrame: 12 months after DBS
Other outcomes:
Locations:
city: Jinan
country: China
facility: Chao Zhang
state: Sichuan
Study officials:
References: