Clinical trial NCT05416905: Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Official title: Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Craniofacial Dystonia
Deep Brain Stimulation
Keywords: Craniofacial Dystonia
Deep Brain Stimulation
Globus pallidus internus
Subthalamic nucleus
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Peking University People's Hospital
name: Civil Aviation General Hospital
name: Chinese PLA General Hospital
name: Beijing Pins Medical Co., Ltd
name: Shandong University of Traditional Chinese Medicine
name: Qilu Hospital of Shandong University
name: Beijing Fengtai Hospital
First posted: 2022-06-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365
timeFrame: 365 days postoperatively compared between groups
Secondary outcomes:
measure: Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90
timeFrame: 90 days postoperatively compared between groups
measure: Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180
timeFrame: 180 days postoperatively compared between groups]
measure: Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference
timeFrame: 365 days postoperatively compared between groups
measure: Blepharospasm disability index (BDSI) difference
timeFrame: 365 days postoperatively compared between groups
measure: Jankovic rating scale (JRS) difference
timeFrame: 365 days postoperatively compared between groups
measure: Mini-mental state examination (MMSE) difference
timeFrame: 365 days postoperatively compared between groups
measure: Montreal cognitive assessment (MoCA) difference
timeFrame: 365 days postoperatively compared between groups
measure: Hamilton depression scale (HRSD) difference
timeFrame: 365 days postoperatively compared between groups
measure: Hamilton anxiety scale (HAMA) difference
timeFrame: 365 days postoperatively compared between groups
measure: Medical outcomes study shortform-36 (SF-36) difference
timeFrame: 365 days postoperatively compared between groups
measure: Programming parameters difference
timeFrame: 365 days postoperatively compared between groups
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jianguo Zhang, MD, PhD
role: STUDY_CHAIR
References: