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

NCT04618887 | Unknown

• 1 other identifier: MeigeSyndrome
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

deep brain stimulation; DBS; DBNL; GPi; pallidotomy

Outcome Measures

Primary Outcomes (2)

• Symptom

  spasm of eyelid

  2 years

• complications

  Postoperative complications

  2 years

Secondary Outcomes (2)

• quality of life

  2 years

• depression scale

  2 years

Study Arms (1)

Meige sydrome patients

Procedure: pallidotomy; Procedure: deep brain stimulation

Interventions

pallidotomy PROCEDURE

deep brain nuclei lesion of GPi

Meige sydrome patients

deep brain stimulation PROCEDURE

deep brain stimulation of GPi

Meige sydrome patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lack of incidence of Meige sydrome，and also lack of efficient of DBS or pallidotomy of Meige Syndrome. We try to collect more data as we can. We initially established a population of 100.

You may qualify if:

• Patients confirmed Meige sydrome

You may not qualify if:

• Patients who cannot finish the neurosurgery or the postoperative evaluation

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Meige Syndrome; Meigs Syndrome; Lymphedema, Hereditary, II; Blepharospasm

Interventions

Pallidotomy; Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dystonic Disorders; Movement Disorders; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative; Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PekingUPH

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 6, 2020
• Study Start: January 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

CN (1)