Craniofacial Dystonia, Deep Brain Stimulation
Conditions
Keywords
Craniofacial Dystonia, Deep Brain Stimulation, Globus pallidus internus, Subthalamic nucleus
Brief 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.
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.
Interventions
DEVICESTN-DBS
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.
DEVICEGPi-DBS
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.
Sponsors
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
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adult subject (male or female, 18-75 years); 2. 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; 3. Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect; 4. Normal cognitive function with MMSE score ≥ 24; 5. Informed consent signed.
Exclusion criteria
1. Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region; 2. Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.); 3. History of brain surgery; 4. Severe depression with HRSD score ≥ 35; 5. Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc); 6. Contraindications to CT or MRI scanning(claustrophobia, etc); 7. pregnant or breastfeeding female, or has positive pregnancy test prior to randomization; 8. Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.); 9. Expected lifetime \< 12 months; 10. Currently receiving an investigational drug or device; 11. 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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180 | 180 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 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. |
| Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference | 365 days postoperatively compared between groups | 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. |
| Blepharospasm disability index (BDSI) difference | 365 days postoperatively compared between groups | 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. |
| Jankovic rating scale (JRS) difference | 365 days postoperatively compared between groups | 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. |
| Mini-mental state examination (MMSE) difference | 365 days postoperatively compared between groups | 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. |
| Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90 | 90 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 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. |
| Hamilton depression scale (HRSD) difference | 365 days postoperatively compared between groups | 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. |
| Hamilton anxiety scale (HAMA) difference | 365 days postoperatively compared between groups | 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. |
| Medical outcomes study shortform-36 (SF-36) difference | 365 days postoperatively compared between groups | 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. |
| Programming parameters difference | 365 days postoperatively compared between groups | 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. |
| Montreal cognitive assessment (MoCA) difference | 365 days postoperatively compared between groups | 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. |
Countries
China
Contacts
Primary ContactYutong Bai, MD, PhD
Outcome results
None listed