Actively Recruiting
Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus internus or Subthalamic Nucleus
Led by Beijing Tiantan Hospital · Updated on 2025-04-22
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the effects of deep brain stimulation (DBS) in patients with idiopathic craniofacial dystonia, a condition causing involuntary muscle contractions in the face. The study compares two DBS targets, the subthalamic nucleus (STN) and the globus pallidus internus (GPi), to see if STN-DBS is not worse than GPi-DBS in improving motor symptoms one year after surgery. The trial is prospective, multicenter, randomized, and controlled, focusing on motor improvements measured by specific rating scales over time. Participants will be randomly assigned to receive DBS targeting either the STN or GPi under local and general anesthesia. The stimulator device will be activated three weeks after surgery to allow brain recovery. Those previously treated with medication will continue their treatment, while those without prior medication will avoid dystonia-related drugs. Assessments will occur at several intervals, including 90, 180, and 365 days postoperatively, evaluating motor function and other neurological and mental health aspects. Throughout the study, patients will undergo various clinical assessments including the Burke-Fahn-Marsden dystonia rating scale, blepharospasm disability index, cognitive tests, and mental health evaluations. Researchers will monitor device programming parameters and changes in motor symptoms over one year. The trial includes safety and functional outcome monitoring, with data collected at multiple time points to assess and compare the two treatments' effects on idiopathic craniofacial dystonia.
CONDITIONS
Brief Title
Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with idiopathic craniofacial dystonia for more than 1 year involving at least the eye or oromandibular region
- May have cervical dystonia
- Previous treatment with oral drugs or botulinum toxin injections without satisfactory effect
- Normal cognitive function with Mini-Mental State Examination score of 24 or higher
- Signed informed consent
You will not qualify if you...
- Only cervical dystonia or dystonia in other body parts besides the cervical region
- Diagnosed with other neuropsychiatric diseases such as Alzheimer's disease, amyotrophic lateral sclerosis, or Parkinson's disease
- History of brain surgery
- Severe depression with Hamilton Depression Scale score of 35 or higher
- Contraindications to neurosurgery such as cerebral infarction, hydrocephalus, cerebral atrophy, or cerebrovascular disease sequelae
- Contraindications to CT or MRI scanning such as claustrophobia
- Pregnant or breastfeeding women or positive pregnancy test before randomization
- Contraindications to general anesthesia including severe arrhythmia, severe anemia, or abnormal liver and kidney function
- Expected life expectancy less than 12 months
- Currently receiving another investigational drug or device
- Other conditions that make participation unsafe or unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Surgery day plus 3 weeks until stimulator activation
Participants undergo deep brain electrode implantation targeting either the STN or GPi under anesthesia, followed by immediate post-operative care including a 3-week recovery period before the stimulator is switched on.
1 surgery visit and initial post-operative visits
Duration - Up to 365 days postoperatively
Participants receive active deep brain stimulation treatment with either STN-DBS or GPi-DBS, with ongoing clinical assessments of motor and cognitive function.
Visits at approximately 90, 180, and 365 days postoperatively
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yutong Bai, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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