Craniofacial DystoniaMEIGESNCT05416905
Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
A study testing STN-DBS and GPi-DBS in people with Craniofacial Dystonia and Deep Brain Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Craniofacial Dystonia, Deep Brain Stimulation
- What is being tested?
- STN-DBS and GPi-DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2022to 30 May 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subject (male or female, 18-75 years);
- Diagnosed with idiopathic craniofacial dystonia for more than 1 year, including at least one of the eye and oromandibular region. Cervical dystonia may be present;
- Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;
- Normal cognitive function with MMSE score ≥ 24;
- Informed consent signed.
Who cannot join
- Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;
- Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);
- History of brain surgery;
- Severe depression with HRSD score ≥ 35;
- Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);
- Contraindications to CT or MRI scanning(claustrophobia, etc);
Show all 11Show fewer
- pregnant or breastfeeding female, or has positive pregnancy test prior to randomization;
- Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.);
- Expected lifetime < 12 months;
- Currently receiving an investigational drug or device;
- Other circumstances that the investigator considers unsuitable to participate in this study or that may pose a significant risk to the patient (inability to understand or comply with research procedures and follow-up, etc.).
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
Beijing Tiantan Hospital
Beijing
Jianguo Zhang, MD, PhD, +86-13601294613, zjguo73@126.com
About this study
Official title: Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus
MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.
Read the detailed description
Evaluating therapeutic effects of GPi-DBS vs. STN-DBS on patients with idiopathic craniofacial dystonia: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The main purpose is to assess whether STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.
Primary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.
Secondary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 90, 180 days (±14 days) after STN-DBS and GPi-DBS. Differences between the two groups in BFMDRS-D, BDSI, JRS, MMSE, MoCA, HRSD, HAMA, SF-36 and programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.
- Conditions
- Craniofacial Dystonia, Deep Brain Stimulation
- Being tested
- STN-DBS, GPi-DBS
- Keywords
- Craniofacial Dystonia, Deep Brain Stimulation, Globus pallidus internus, Subthalamic nucleus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN-DBSDevice
Also called subthalamic necleus-deep brain stimulation
The patients will be treated with deep brain electrode placement of STN target under local and general anesthesia. Switching the system on: the stimulator will be switched on 3 weeks after surgery to allow time for the brain edema and "stun effect" to wear off. Postoperative medication: The subject taking medication in the past will continue the medication. If the subject with no medication before, will be required not to take medication related to dystonia.
GPi-DBSDevice
Also called globus pallidus internus-deep brain stimulation
The patients will be treated with deep brain electrode implantation of GPi target under local and general anesthesia. Except that the surgical target was GPi, the operation process, stimulator switch-on time, and postoperative medication were the same as those in the STN-DBS group.
| Study group | Role | What they receive |
|---|---|---|
| STN-DBS | Experimental | The patients in this group will be treated with STN-DBS. Receives: Device: STN-DBS |
| GPi-DBS | Active comparator | The patients in this group will be treated with GPi-DBS. Receives: Device: GPi-DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.
Measured: 365 days postoperatively compared between groups
Secondary outcomes (11)
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 90 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.
Measured: 90 days postoperatively compared between groups
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 180 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.
Measured: 180 days postoperatively compared between groups]
Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-D contains 7 items of 0-30 and higher scores indicate a worse outcome.
Measured: 365 days postoperatively compared between groups
Blepharospasm disability index (BDSI) difference
Differences between the two groups in the change of Blepharospasm disability index (BDSI) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BDSI contains 6 items of 0-4 (average socre) and higher scores indicate a worse outcome.
Measured: 365 days postoperatively compared between groups
Jankovic rating scale (JRS) difference
Differences between the two groups in the change of Jankovic rating scale (JRS) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. JRS contains 2 items of 0-8 and higher scores indicate a worse outcome.
Measured: 365 days postoperatively compared between groups
Mini-mental state examination (MMSE) difference
Differences between the two groups in the change of mini-mental state examination (MMSE) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. MMSE contains 30 questions of 0-30 and higher scores indicate a better outcome.
Measured: 365 days postoperatively compared between groups
Montreal cognitive assessment (MoCA) difference
Differences between the two groups in the change of Montreal cognitive assessment (MoCA) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. MoCA contains 8 modules of 0-30 and higher scores indicate a better outcome.
Measured: 365 days postoperatively compared between groups
Hamilton depression scale (HRSD) difference
Differences between the two groups in the change of Hamilton depression scale (HRSD) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. HRSD contains 24 items of 24-77 and higher scores indicate a worse outcome.
Measured: 365 days postoperatively compared between groups
Hamilton anxiety scale (HAMA) difference
Differences between the two groups in the change of Hamilton anxiety scale (HAMA) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. HAMA contains 14 items of 0-56 and higher scores indicate a worse outcome.
Measured: 365 days postoperatively compared between groups
Medical outcomes study shortform-36 (SF-36) difference
Differences between the two groups in the change of medical outcomes study shortform-36 (SF-36) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. SF-36 contains 8 modules of 0-100 and higher scores indicate a better outcome.
Measured: 365 days postoperatively compared between groups
Programming parameters difference
Differences between the two groups in programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment, including total electrical energy delivered (TEED), contact, voltage, pulse width and frequency.
Measured: 365 days postoperatively compared between groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start22 Jun 2022
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial DystoniaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University People's Hospital, Civil Aviation General Hospital, Chinese PLA General Hospital, Beijing Pins Medical Co., Ltd, Shandong University of Traditional Chinese Medicine, Qilu Hospital of Shandong University, Beijing Fengtai Hospital
- Responsible party
- Principal investigator, Jianguo Zhang, Beijing Tiantan Hospital
- Investigators
- Jianguo Zhang, MD, PhD, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416905
- Sponsor's protocol ID
- HX-A-2022022
- Acronym
- MEIGES
- Status last verified
- Apr 2025
- First submitted
- 9 Jun 2022
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus
- ClinicalTrials.gov ID
- NCT05416905
- Acronym / sponsor ID
- MEIGES / HX-A-2022022
- Conditions
- Craniofacial Dystonia, Deep Brain Stimulation
- Keywords
- Craniofacial Dystonia, Deep Brain Stimulation, Globus pallidus internus, Subthalamic nucleus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University People's Hospital, Civil Aviation General Hospital, Chinese PLA General Hospital, Beijing Pins Medical Co., Ltd, Shandong University of Traditional Chinese Medicine, Qilu Hospital of Shandong University, Beijing Fengtai Hospital
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 14 Jun 2022 (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.
MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.
Detailed description
Evaluating therapeutic effects of GPi-DBS vs. STN-DBS on patients with idiopathic craniofacial dystonia: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The main purpose is to assess whether STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.
Primary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.
Secondary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 90, 180 days (±14 days) after STN-DBS and GPi-DBS. Differences between the two groups in BFMDRS-D, BDSI, JRS, MMSE, MoCA, HRSD, HAMA, SF-36 and programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STN-DBS | Experimental | Device: STN-DBSThe patients in this group will be treated with STN-DBS. |
| GPi-DBS | Active comparator | Device: GPi-DBSThe patients in this group will be treated with GPi-DBS. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subject (male or female, 18-75 years);
- Diagnosed with idiopathic craniofacial dystonia for more than 1 year, including at least one of the eye and oromandibular region. Cervical dystonia may be present;
- Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;
- Normal cognitive function with MMSE score ≥ 24;
- Informed consent signed.
Key exclusion criteria (11 listed)
- Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;
- Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);
- History of brain surgery;
- Severe depression with HRSD score ≥ 35;
- Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);
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 |
|---|---|---|
| STN-DBSAlso: subthalamic necleus-deep brain stimulationThe patients will be treated with deep brain electrode placement of STN target under local and general anesthesia. Switching the system on: the stimulator will be switched on 3 weeks after surgery to allow time for the brain edema and "stun effect" to wear off. Postoperative medication: The subject taking medication in the past will continue the medication. If the subject with no medication before, will be required not to take medication related to dystonia. | Device | STN-DBS |
| GPi-DBSAlso: globus pallidus internus-deep brain stimulationThe patients will be treated with deep brain electrode implantation of GPi target under local and general anesthesia. Except that the surgical target was GPi, the operation process, stimulator switch-on time, and postoperative medication were the same as those in the STN-DBS group. | Device | GPi-DBS |
Primary outcome
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365
Time frame: 365 days postoperatively compared between groups
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.
11 secondary outcomes
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90
Time frame: 90 days postoperatively compared between groups
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180
Time frame: 180 days postoperatively compared between groups]
Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference
Time frame: 365 days postoperatively compared between groups
Blepharospasm disability index (BDSI) difference
Time frame: 365 days postoperatively compared between groups
Jankovic rating scale (JRS) difference
Time frame: 365 days postoperatively compared between groups
Mini-mental state examination (MMSE) difference
Time frame: 365 days postoperatively compared between groups
Montreal cognitive assessment (MoCA) difference
Time frame: 365 days postoperatively compared between groups
Hamilton depression scale (HRSD) difference
Time frame: 365 days postoperatively compared between groups
Hamilton anxiety scale (HAMA) difference
Time frame: 365 days postoperatively compared between groups
Medical outcomes study shortform-36 (SF-36) difference
Time frame: 365 days postoperatively compared between groups
Programming parameters difference
Time frame: 365 days postoperatively compared between groups
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 22 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Craniofacial Dystonia
Recruiting
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
RecruitingObservational study
Neurosurgical Outcome Network
Aneurysms, Arteriovenous Malformations
RecruitingObservational study
Brain Networks in Dystonia
Spasmodic Dysphonia, Singer's Dystonia
RecruitingObservational study
Register for Patients With Thyroid Hormone Resistance.
Hypothyroidism, Global Developmental Delay
Enrolling by invitation
Newborn Head Molding and Later Asymmetries
Plagiocephaly
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.
Jianguo Zhang, MD, PhD study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STN-DBS and GPi-DBS in people with Craniofacial Dystonia and Deep Brain Stimulation, run by Beijing Tiantan 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 5 inclusion and 11 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 22 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?
Contact Yutong Bai, MD, PhD (13611420134, baiyutong88@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365 (time frame: 365 days postoperatively compared between groups). 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 22 Apr 2025.