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NCT04618887 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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