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Status unknownNCT04618887Updated Nov 6, 2020

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

An observational study in Meige Syndrome, Meigs Syndrome and Meige Disease, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • deep brain stimulation
  • DBS
  • DBNL
  • GPi
  • pallidotomy
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In context

Blepharospasm

42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.

This study's planned enrollment of 100 is below the median of 115 across 14 observational studies indexed under Blepharospasm.

Browse Blepharospasm studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients confirmed Meige sydrome

Exclusion criteria

Exclusion Criteria:

  • Patients who cannot finish the neurosurgery or the postoperative evaluation
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Meige sydrome patients

    Procedure: pallidotomy · Procedure: deep brain stimulation

Interventions

  • Procedurepallidotomy

    deep brain nuclei lesion of GPi

  • Proceduredeep brain stimulation

    deep brain stimulation of GPi

06

What researchers measure

Primary outcomes

  1. Symptom

    spasm of eyelid

    Time frame: 2 years

  2. complications

    Postoperative complications

    Time frame: 2 years

Secondary outcomes

  1. quality of life

    Evaluate using SF-36

    Time frame: 2 years

  2. depression scale

    Evaluate using Hamilton Depression Scale

    Time frame: 2 years

07

Study locations

1 site
  • Peking University People's Hospital
    Beijing, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2020 (actual). Primary completion is estimated for Nov 2022, 34 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2020
First posted
Nov 6, 2020
StartActual
Jan 1, 2020
Primary completionEst.
Nov 2022
CompletionEst.
Dec 2023
Last update
Nov 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04618887
Responsible party
Liu Ruen (PekingUPH, Peking University People's Hospital) — Principal investigator
First posted
Nov 6, 2020
Start date
Jan 1, 2020
Primary completion
Nov 2022 (estimated)
Completion
Dec 2023 (estimated)
Last update
Nov 6, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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