Meige SyndromeNCT06292559
A Comparison Between STN-DBS and GPi-DBS in Meige Syndrome Evaluated by Flexible Electrodes
A study testing Bilateral STN deep brain stimulation and Bilateral GPi deep brain stimulation in people with Meige Syndrome, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Meige Syndrome
- What is being tested?
- Bilateral STN deep brain stimulation and Bilateral GPi deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Meige syndrome was diagnosed by an experienced neurologist.
- All patients had received systematic and regular treatment for at least 1 year before surgery, including oral drugs and local injection of botulinum toxin A, but the efficacy was not apparent, as the ability to engage with daily life and the quality of life of the patients significantly decreased.
- Tere were no other serious systemic diseases, such as severe organic heart disease, severe lung, liver and kidney dysfunction, and coagulation dysfunction.
- Tere was no history of neurological diseases other than Meige syndrome, such as Parkinson's disease or severe cognitive dysfunction.
- Tere were no serious psychiatric disorders, such as schizophrenia.
- Preoperative head magnetic resonance imaging (MRI) examinations were normal. Patients of missing follow-up and incomplete clinical data were excluded from the cases.
Who cannot join
- Unilateral facial spas and blepharospasm.
- Patients with severe disease such as coronary heart disease, stroke.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chao Zhang
Jinan, Shandong, 250100
chao zhang, +8613969007232, chao_zhang@sdu.edu.cn
About this study
Official title: A Randomized Prospective Study Between STN-DBS and GPi-DBS in Meige Syndrome
Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Researchers designed this study to compare the 12-month outcomes for patients who undergo bilateral stimulation of the GPi or STN.
Read the detailed description
Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are accepted targets for this treatment. Researchers are willing to compared12-month outcomes for patients who had undergone bilateral stimulation of the GPi or STN. Forty-two Asian patients with primary Meige syndrome who underwent GPi or STN neurostimulation were recruited between Nov. 2023 and Nov. 2025 at the Department of Neurosurgery, Qilu Hospital. The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M) and disability subscale (BFMDRS-D) at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery. Secondary outcomes included health-related quality of life, sleep quality status, depression severity, and anxiety severity at 3 days before and 12 months after DBS surgery.
- Conditions
- Meige Syndrome
- Being tested
- Bilateral STN deep brain stimulation, Bilateral GPi deep brain stimulation
- Keywords
- DBS, STN vs GPi
- Medical subject headings
- Meige Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral STN deep brain stimulationDevice
patients with Meige syndrome underwent bilateral subthalamic stimulation
Bilateral GPi deep brain stimulationDevice
patients with Meige syndrome underwent bilateral pallidal stimulation
| Study group | Role | What they receive |
|---|---|---|
| Bilateral STN deep brain stimulation | Placebo comparator | Patients with Meige syndrome accepted STN DBS Receives: Device: Bilateral STN deep brain stimulation |
| Bilateral GPi deep brain stimulation | Experimental | Patients with Meige syndrome accepted GPi DBS Receives: Device: Bilateral GPi deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor function
The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M)at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery.
Measured: 12 months after DBS
Secondary outcomes (4)
health-related quality of life
Secondary outcomes included health-related quality of life (EuroQol Five Dimensions Questionnaire) at 3 days before and 12 months after DBS surgery.
Measured: 12 months after DBS
sleep quality status
Secondary outcomes included sleep quality status (Pittsburgh Sleep Quality Index) at 3 days before and 12 months after DBS surgery.
Measured: 12 months after DBS
Mental syndrome
Secondary outcomes included depression severity, and anxiety severity including Hamilton Depression Scale (HAMD) scores at 3 days before and 12 months after DBS surgery.
Measured: 12 months after DBS
Mental syndrome
Secondary outcomes included depression severity, and anxiety severity including Hamilton Anxiety Scale (HAMA) scores at 3 days before and 12 months after DBS surgery.
Measured: 12 months after DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start30 Nov 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2025 (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.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292559
- Sponsor's protocol ID
- STN or GPi in Meige Syndrom
- Status last verified
- Nov 2023
- First submitted
- 16 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study Between STN-DBS and GPi-DBS in Meige Syndrome
- ClinicalTrials.gov ID
- NCT06292559
- Acronym / sponsor ID
- STN or GPi in Meige Syndrom
- Conditions
- Meige Syndrome
- Keywords
- DBS, STN vs GPi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 5 Mar 2024 (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.
Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Researchers designed this study to compare the 12-month outcomes for patients who undergo bilateral stimulation of the GPi or STN.
Detailed description
Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are accepted targets for this treatment. Researchers are willing to compared12-month outcomes for patients who had undergone bilateral stimulation of the GPi or STN. Forty-two Asian patients with primary Meige syndrome who underwent GPi or STN neurostimulation were recruited between Nov. 2023 and Nov. 2025 at the Department of Neurosurgery, Qilu Hospital. The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M) and disability subscale (BFMDRS-D) at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery. Secondary outcomes included health-related quality of life, sleep quality status, depression severity, and anxiety severity at 3 days before and 12 months after DBS surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral STN deep brain stimulation | Placebo comparator | Device: Bilateral STN deep brain stimulationPatients with Meige syndrome accepted STN DBS |
| Bilateral GPi deep brain stimulation | Experimental | Device: Bilateral GPi deep brain stimulationPatients with Meige syndrome accepted GPi DBS |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary Meige syndrome was diagnosed by an experienced neurologist.
- All patients had received systematic and regular treatment for at least 1 year before surgery, including oral drugs and local injection of botulinum toxin A, but the efficacy was not apparent, as the ability to engage with daily life and the quality of life of the patients significantly decreased.
- Tere were no other serious systemic diseases, such as severe organic heart disease, severe lung, liver and kidney dysfunction, and coagulation dysfunction.
- Tere was no history of neurological diseases other than Meige syndrome, such as Parkinson's disease or severe cognitive dysfunction.
- Tere were no serious psychiatric disorders, such as schizophrenia.
Key exclusion criteria (2 listed)
- Unilateral facial spas and blepharospasm.
- Patients with severe disease such as coronary heart disease, stroke.
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 |
|---|---|---|
| Bilateral STN deep brain stimulationpatients with Meige syndrome underwent bilateral subthalamic stimulation | Device | Bilateral STN deep brain stimulation |
| Bilateral GPi deep brain stimulationpatients with Meige syndrome underwent bilateral pallidal stimulation | Device | Bilateral GPi deep brain stimulation |
Primary outcome
Change in motor function
Time frame: 12 months after DBS
The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M)at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery.
4 secondary outcomes
health-related quality of life
Time frame: 12 months after DBS
sleep quality status
Time frame: 12 months after DBS
Mental syndrome
Time frame: 12 months after DBS
Mental syndrome
Time frame: 12 months after DBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Spasmodic Dysphonia, Singer's Dystonia
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Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome
Meige Syndrome
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral STN deep brain stimulation and Bilateral GPi deep brain stimulation in people with Meige Syndrome, run by Qilu Hospital of Shandong University 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chao zhang (053182166631, chao_zhang@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor function (time frame: 12 months after DBS). 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 5 Mar 2024.