Comparing brain stimulation techniques for treating craniocervical dystonia
Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation
This study is testing which of two brain stimulation targets can better help people with craniocervical dystonia improve their symptoms and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06480188 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in brain network mechanisms between two deep brain stimulation (DBS) targets, the Subthalamic Nucleus (STN) and the Globus Pallidus internus (GPi), in patients with craniocervical dystonia. It aims to assess the effects of DBS on symptoms such as dysarthria and dysphagia, as well as evaluate the efficacy, quality of life, and side effects associated with each target. The study will utilize advanced imaging techniques to analyze brain activity and electrophysiological signals during DBS surgery to enhance treatment programming.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 diagnosed with primary craniocervical dystonia and experiencing symptoms for at least one year.
Not a fit: Patients with other forms of dystonia, significant neuropsychiatric disorders, or contraindications to surgery or imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients suffering from craniocervical dystonia.
How similar studies have performed: While there is existing research on DBS for dystonia, this specific comparison of STN and GPi mechanisms is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-75 years 2. Meeting the diagnostic criteria for primary craniocervical dystonia (including patients with cranial, cervical, or unilateral extremity dystonia) 3. Disease duration ≥1 year 4. Normal cognitive function 5. The subject himself or his legal representative can sign the informed consent form Exclusion Criteria: 1. Patients with other dystonia who did not meet the inclusion criteria 2. Diagnosed with other neuropsychiatric diseases (Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.) 3. Previous history of craniocerebral surgery 4. Major depression or anxiety 5. The presence of neurosurgical contraindications such as cerebral infarction, hydrocephalus, cerebral atrophy, and sequelae of cerebrovascular disease 6. Contraindications to CT/MRI scanning (e.g. Claustrophobia) 7. women known to be pregnant or lactating, or who had a positive pregnancy test before randomization 8. Presence of contraindications to general anesthesia (such as severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.) 9. Expected survival less than 12 months 10. has participated in other interventional clinical studies that may have affected the outcome assessment 11. other circumstances considered by the investigator to be inappropriate for participation in the study or likely to pose a significant risk to the patient
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of Ustc — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Chaoshi Niu
- Email: niuchaoshi@163.com
- Phone: 13855186208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.