A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome

• Conditions: Meige Disease; Meig Syndrome; Blepharospasm; Blepharospasm Oromandibular Dystonia; Meigs Syndrome; Meige Syndrome; Blepharospasm of Left Eyelid; Blepharospasm of Right Eyelid; Blepharospasm of Both Eyelids
• Interventions: Procedure: pallidotomy; Procedure: deep brain stimulation

• Registration Number: NCT04618887
• Lead Sponsor: Peking University People's Hospital

Brief Summary

In this study, we will compare the degree of postoperative symptom improvement, postoperative complication rate, postoperative quality of life improvement degree of patients with Meige syndrome undergoing pallidotomy (unilateral globus palliotomy) and deep brain stimulation (unilateral globus pallidus) ,in order to get the conclusion of the comparison of the clinical efficacy of the two surgical plans. In addition, possible predictive factors such as age, gender, age of onset, length of disease course, scale baseline score, preoperative brain PET-CT function analysis and other possible predictive factors are added for analysis, in order to find predictive factors that can guide the choice of surgical options.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-01
• Last Update Submitted: 2020-11-01
• Study First Posted: 2020-11-06
• Last Update Posted: 2020-11-06
• Primary Completion: 2022-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients confirmed Meige sydrome

Exclusion Criteria

• Patients who cannot finish the neurosurgery or the postoperative evaluation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Meige sydrome patients	pallidotomy	-
Meige sydrome patients	deep brain stimulation	-

Primary Outcome Measures

Name	Time	Method
Symptom	2 years	spasm of eyelid
complications	2 years	Postoperative complications

Secondary Outcome Measures

Name	Time	Method
quality of life	2 years	Evaluate using SF-36
depression scale	2 years	Evaluate using Hamilton Depression Scale

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China