Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

Launched by BEIJING TIANTAN HOSPITAL · Jun 9, 2022

Keywords

ClinConnect Summary

This clinical trial, called MEIGES, is exploring the effects of two types of deep brain stimulation (DBS) treatments for people with idiopathic craniofacial dystonia, a condition that causes involuntary muscle contractions in the face and neck. The study aims to find out if one type of stimulation, targeting the subthalamic nucleus (STN), is just as effective as another type that targets the globus pallidus internus (GPi) in improving motor symptoms after one year.

To participate, individuals need to be between 18 and 75 years old and have been diagnosed with craniofacial dystonia for over a year, with symptoms that haven’t improved with medications or botulinum toxin injections. Participants will undergo surgery for the DBS treatment and will be monitored for a year to see how well their symptoms improve. This trial is currently recruiting participants and aims to provide valuable insights into the best treatment options for this challenging condition.

Gender

ALL

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.).