Comparing two types of deep brain stimulation for craniofacial dystonia

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

This study is testing whether a new type of brain stimulation can help people with craniofacial dystonia feel better compared to a standard method after a year.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05416905 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of two different deep brain stimulation techniques, GPi-DBS and STN-DBS, in treating idiopathic craniofacial dystonia. It is a multicenter, randomized controlled trial that aims to determine if STN-DBS is as effective as GPi-DBS in improving motor symptoms after one year. Clinical data will be collected at various time points to assess changes in symptoms using standardized assessments. The primary focus is on comparing the improvement in motor symptoms at 365 days post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 diagnosed with idiopathic craniofacial dystonia for over a year who have not responded satisfactorily to other treatments.

Not a fit: Patients with only cervical dystonia or those with other neuropsychiatric diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a more effective treatment option for managing craniofacial dystonia.

How similar studies have performed: Previous studies have shown varying success with deep brain stimulation techniques, but this specific comparison of GPi-DBS and STN-DBS for craniofacial dystonia is relatively novel.

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.).

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yutong Bai, MD, PhD

Conditions: Craniofacial Dystonia, Deep Brain Stimulation, Globus pallidus internus, Subthalamic nucleus