Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
NCT ID: NCT05416905
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2022-06-22
2025-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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STN-DBS
The patients in this group will be treated with STN-DBS.
STN-DBS
The patients will be treated with deep brain electrode placement of STN target under local and general anesthesia. Switching the system on: the stimulator will be switched on 3 weeks after surgery to allow time for the brain edema and "stun effect" to wear off. Postoperative medication: The subject taking medication in the past will continue the medication. If the subject with no medication before, will be required not to take medication related to dystonia.
GPi-DBS
The patients in this group will be treated with GPi-DBS.
GPi-DBS
The patients will be treated with deep brain electrode implantation of GPi target under local and general anesthesia. Except that the surgical target was GPi, the operation process, stimulator switch-on time, and postoperative medication were the same as those in the STN-DBS group.
Interventions
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STN-DBS
The patients will be treated with deep brain electrode placement of STN target under local and general anesthesia. Switching the system on: the stimulator will be switched on 3 weeks after surgery to allow time for the brain edema and "stun effect" to wear off. Postoperative medication: The subject taking medication in the past will continue the medication. If the subject with no medication before, will be required not to take medication related to dystonia.
GPi-DBS
The patients will be treated with deep brain electrode implantation of GPi target under local and general anesthesia. Except that the surgical target was GPi, the operation process, stimulator switch-on time, and postoperative medication were the same as those in the STN-DBS group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.).
18 Years
75 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Peking University People's Hospital
OTHER
Civil Aviation General Hospital
OTHER
Chinese PLA General Hospital
OTHER
Beijing Pins Medical Co., Ltd
INDUSTRY
Shandong University of Traditional Chinese Medicine
OTHER
Qilu Hospital of Shandong University
OTHER
Beijing Fengtai Hospital
UNKNOWN
Beijing Tiantan Hospital
OTHER
Responsible Party
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Jianguo Zhang
Director of Department of Functional Neurosurgery
Principal Investigators
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Jianguo Zhang, MD, PhD
Role: STUDY_CHAIR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HX-A-2022022
Identifier Type: -
Identifier Source: org_study_id
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