Comparing two deep-brain stimulation methods for Meige syndrome
A Randomized Prospective Study Between STN-DBS and GPi-DBS in Meige Syndrome
NA · Qilu Hospital of Shandong University · NCT06292559
This study is testing which of two brain stimulation methods helps people with Meige syndrome improve their movement and daily life better over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University (other) |
| Locations | 1 site (Jinan, Sichuan) |
| Trial ID | NCT06292559 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of bilateral deep-brain stimulation (DBS) targeting either the globus pallidus interna (GPi) or the subthalamic nucleus (STN) in patients with Meige syndrome. A total of 42 patients diagnosed with primary Meige syndrome will be recruited and monitored over a 12-month period. The primary outcomes will focus on changes in motor function and disability, assessed using the Burke-Fahn-Marsden Dystonia Rating Scale. Secondary outcomes will include evaluations of health-related quality of life, sleep quality, and mental health indicators such as depression and anxiety.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with primary Meige syndrome who have not responded adequately to conventional treatments.
Not a fit: Patients with unilateral facial spasms or those with other neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective DBS target for improving motor function and quality of life in patients with Meige syndrome.
How similar studies have performed: Other studies have shown promising results with DBS for movement disorders, but this specific comparison between GPi and STN in Meige syndrome is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan, Sichuan
- Chao Zhang — Jinan, Sichuan, China (RECRUITING)
Study contacts
- Study coordinator: chao zhang
- Email: chao_zhang@sdu.edu.cn
- Phone: 053182166631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Meige Syndrome, DBS, STN vs GPi