Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus

Conditions
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Craniofacial Dystonia, Deep Brain Stimulation

Intervention / Treatment
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* Device: STN-DBS
* Device: GPi-DBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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); 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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STN-DBS<br>The patients in this group will be treated with STN-DBS. | Device: STN-DBS<br>* 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.<br>* Other names: subthalamic necleus-deep brain stimulation;|
| Active Comparator: GPi-DBS<br>The patients in this group will be treated with GPi-DBS. | Device: GPi-DBS<br>* 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.<br>* Other names: globus pallidus internus-deep brain stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 365 days postoperatively compared between groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 365 days postoperatively compared between groups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniofacial Dystonia, Deep Brain Stimulation, Globus pallidus internus, Subthalamic nucleus