NCT06912282

Brief Summary

Meige syndrome is a rare and debilitating movement disorder characterized by blepharospasm, oromandibular dystonia, and cervical muscle contractions, often refractory to pharmacological therapies. Deep brain stimulation (DBS), initially developed to treat essential tremor and Parkinson's disease, has been explored in recent years as a potential treatment for various dystonias, including Meige's syndrome. This clinical study aims to evaluate the safety and efficacy of bilateral single-electrode ventralis oralis (VO) nucleus stimulation combined with subthalamic nucleus deep brain stimulation (STN-DBS) in patients with Meige syndrome.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Mar 2025Jan 2027

Study Start

First participant enrolled

March 6, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

March 26, 2025

Last Update Submit

March 30, 2025

Conditions

Meige Syndrome

Keywords

DBS

Outcome Measures

Primary Outcomes (1)

  • Improvement of primary symptoms

    Scale title: Burke-Fahn-Marsden Dystonia Rating Scale Section I: Motor subscale (0-120) Section II: Disability scale (0-30) Higher scores: Indicate worse outcomes (more severe dystonia symptoms).

    1 year after stimulation

Secondary Outcomes (9)

  • Improvement of symptoms

    1 year after stimulation

  • Improvement of symptoms

    1 year after stimulation

  • Improvement of symptoms

    1 year after stimulation

  • Improvement of symptoms

    1 year after stimulation

  • Psychological assessment

    1 year after stimulation

  • +4 more secondary outcomes

Study Arms (2)

VO-DBS / VO Combined with STN-DBS Group

EXPERIMENTAL

Patients will undergo bilateral single-electrode VO combined with STN target implantation. After device activation, VO-DBS single-target stimulation will be applied. Evaluation will be conducted after three months, followed by the initiation of combined VO and STN-DBS stimulation.

Device: deep brain stimulation

STN-DBS / VO Combined with STN-DBS Group

ACTIVE COMPARATOR

Patients will undergo bilateral single-electrode VO combined with STN target implantation. After device activation, STN-DBS single-target stimulation will be applied. Evaluation will be conducted after three months, followed by the initiation of combined VO and STN-DBS stimulation.

Device: deep brain stimulation

Interventions

deep brain stimulationDEVICE

bilateral single-electrode VO combined with STN target implantation

STN-DBS / VO Combined with STN-DBS GroupVO-DBS / VO Combined with STN-DBS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must meet the clinical diagnostic criteria for Meige syndrome
  • Only includes patients with: Blepharospasm-type Meige syndrome and Blepharospasm with lower jaw muscle dystonia-type
  • All patients must have undergone at least one year of systematic and standard treatment prior to surgery

You may not qualify if:

  • History of neurological diseases other than Meige syndrome
  • Severe cognitive impairment
  • Severe psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital, Fudan University.

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Meige Syndrome

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDystonic DisordersMovement Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 4, 2025

Study Start

March 6, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 4, 2025

Record last verified: 2025-03

Locations

CN(1)