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

Blepharospasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04618887
• Other study ID #: MeigeSyndrome
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: November 2020
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients confirmed Meige sydrome

Exclusion Criteria:

• Patients who cannot finish the neurosurgery or the postoperative evaluation

Related Conditions & MeSH terms

• Blepharospasm
• Blepharospasm of Both Eyelids
• Blepharospasm of Left Eyelid
• Blepharospasm of Right Eyelid
• Blepharospasm Oromandibular Dystonia
• Dystonia
• Meig Syndrome
• Meige Disease
• Meige Syndrome
• Meigs Syndrome
• Syndrome

Intervention

Procedure:
• pallidotomy
deep brain nuclei lesion of GPi
• deep brain stimulation
deep brain stimulation of GPi

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom	spasm of eyelid	2 years
Primary	complications	Postoperative complications	2 years
Secondary	quality of life	Evaluate using SF-36	2 years
Secondary	depression scale	Evaluate using Hamilton Depression Scale	2 years