Meige SyndromeNCT06912282
Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome
A study testing deep brain stimulation in people with Meige Syndrome, run by Huashan Hospital at 1 site in China.
Trial summary
Meige syndrome is a rare and debilitating movement disorder characterized by blepharospasm, oromandibular dystonia, and cervical muscle contractions, often refractory to pharmacological therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meige Syndrome
- What is being tested?
- deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of neurological diseases other than Meige syndrome
- Severe cognitive impairment
- Severe psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University.
Shanghai, Shanghai Municipality, 200040
Chunhao Zhang, +86-21-52889999, 24111220163@m.fudan.edu.cn
About this study
Official title: Evaluation of Bilateral Single-Electrode VO Combined With STN-DBS Stimulation in the Treatment of Meige Syndrome: A Prospective, Single-Center, Double-Blind, Randomized Controlled Exploratory Clinical Study
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.
Read the detailed description
While deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) or the globus pallidus interna (GPi) has shown moderate efficacy, incomplete symptom relief and high stimulation thresholds with associated side effects remain significant limitations. Emerging evidence suggests that dual-target neuromodulation combining STN with ventralis oralis (VO) nucleus stimulation may synergistically modulate hyperactive basal ganglia-thalamocortical circuits, potentially enhancing therapeutic outcomes.The study will involve patients diagnosed with Meige syndrome who are eligible for DBS therapy. Participants will be randomly assigned to one of two groups.The primary outcome measure is the improvement in motor symptoms, assessed using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) before and after treatment. Secondary outcomes will include changes in quality of life, anxiety and depression scores, and any adverse effects related to the DBS procedure.The results of this study will be used to guide future clinical trials and inform the treatment options for patients with Meige syndrome.
- Conditions
- Meige Syndrome
- Being tested
- deep brain stimulation
- Keywords
- DBS
- Medical subject headings
- Meige Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulationDevice
bilateral single-electrode VO combined with STN target implantation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year after stimulation
Secondary outcomes (9)
Improvement of symptoms
Scale title: Jankovic Rating Scale Minimum value: 0 (No dystonia) Maximum value: 8 (Severe dystonia) Higher scores: Indicate worse outcomes (more severe dystonia symptoms).
Measured: 1 year after stimulation
Improvement of symptoms
Scale title: Blepharospasm Disability Index Minimum value: 0 (No disability) Maximum value: 24 (Severe disability) Higher scores: Indicate worse outcomes (more severe disability due to blepharospasm).
Measured: 1 year after stimulation
Improvement of symptoms
Scale title: Oromandibular Dystonia Questionnaire Minimum value: 0 (No symptoms or disability) Maximum value: 100 (Severe disability) Higher scores: Indicate worse outcomes (more disability due to oromandibular dystonia).
Measured: 1 year after stimulation
Improvement of symptoms
Scale title: Oromandibular Dystonia Rating Scale Minimum value: 0 (No dystonia) Maximum value: 314 (Severe dystonia) Higher scores: Indicate worse outcomes (more severe oromandibular dystonia symptoms).
Measured: 1 year after stimulation
Psychological assessment
Scale title: Hamilton Anxiety Rating Scale Minimum value: 0 (No anxiety) Maximum value: 56 (Severe anxiety) Higher scores: Indicate worse outcomes (more severe anxiety).
Measured: 1 year after stimulation
Psychological assessment
Scale title: Hamilton Depression Rating Scale Minimum value: 0 (No depression) Maximum value: 52 (Severe depression) Higher scores: Indicate worse outcomes (more severe depression).
Measured: 1 year after stimulation
Cognitive assessment
Scale title: Mini-Mental State Examination Minimum value: 0 (Severe cognitive impairment) Maximum value: 30 (No cognitive impairment) Higher scores: Indicate better outcomes (better cognitive function).
Measured: 1 year after stimulation
Cognitive assessment
Scale title: Montreal Cognitive Assessment Minimum value: 0 (Severe cognitive impairment) Maximum value: 30 (No cognitive impairment) Higher scores: Indicate better outcomes (better cognitive function).
Measured: 1 year after stimulation
health-related quality of life
Scale title:Short Form 36 Health Survey
The SF-36 is a widely used tool to assess general health status and quality of life. It includes 36 items that measure eight health domains:
Physical functioning Role limitations due to physical health problems Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health perceptions Each of the domains is scored separately, and the overall score can reflect a person's physical and mental health.
Minimum value: 0 (Worst health status) Maximum value: 100 (Best health status) Higher scores: Indicate better outcomes (better health-related quality of life).
Measured: 1 year after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start6 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meige SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Hu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912282
- Sponsor's protocol ID
- KY2025-084
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bilateral Single-Electrode VO Combined With STN-DBS Stimulation in the Treatment of Meige Syndrome: A Prospective, Single-Center, Double-Blind, Randomized Controlled Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06912282
- Acronym / sponsor ID
- KY2025-084
- Conditions
- Meige Syndrome
- Keywords
- DBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
While deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) or the globus pallidus interna (GPi) has shown moderate efficacy, incomplete symptom relief and high stimulation thresholds with associated side effects remain significant limitations. Emerging evidence suggests that dual-target neuromodulation combining STN with ventralis oralis (VO) nucleus stimulation may synergistically modulate hyperactive basal ganglia-thalamocortical circuits, potentially enhancing therapeutic outcomes.The study will involve patients diagnosed with Meige syndrome who are eligible for DBS therapy. Participants will be randomly assigned to one of two groups.The primary outcome measure is the improvement in motor symptoms, assessed using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) before and after treatment. Secondary outcomes will include changes in quality of life, anxiety and depression scores, and any adverse effects related to the DBS procedure.The results of this study will be used to guide future clinical trials and inform the treatment options for patients with Meige syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VO-DBS / VO Combined with STN-DBS Group | Experimental | Device: deep brain stimulationPatients 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. |
| STN-DBS / VO Combined with STN-DBS Group | Active comparator | Device: deep brain stimulationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- History of neurological diseases other than Meige syndrome
- Severe cognitive impairment
- Severe psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep brain stimulationbilateral single-electrode VO combined with STN target implantation | Device | STN-DBS / VO Combined with STN-DBS Group, VO-DBS / VO Combined with STN-DBS Group |
Primary outcome
Improvement of primary symptoms
Time frame: 1 year after stimulation
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).
9 secondary outcomes
Improvement of symptoms
Time frame: 1 year after stimulation
Improvement of symptoms
Time frame: 1 year after stimulation
Improvement of symptoms
Time frame: 1 year after stimulation
Improvement of symptoms
Time frame: 1 year after stimulation
Psychological assessment
Time frame: 1 year after stimulation
Psychological assessment
Time frame: 1 year after stimulation
Cognitive assessment
Time frame: 1 year after stimulation
Cognitive assessment
Time frame: 1 year after stimulation
health-related quality of life
Time frame: 1 year after stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Meige Syndrome
RecruitingObservational study
Brain Networks in Dystonia
Spasmodic Dysphonia, Singer's Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep brain stimulation in people with Meige Syndrome, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of primary symptoms (time frame: 1 year after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.