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New treatment option for Craniofacial Dystonia
Official title Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
ClinicalTrials.gov ID: NCT05416905
What this study is testing
- What it's testing
- MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adult subject (male or female, 18-75 years);
- Diagnosed with idiopathic craniofacial dystonia for more than 1 year, including at least one of the eye and oromandibular region. Cervical dystonia...
- Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;
- Normal cognitive function with MMSE score ≥ 24;
- Informed consent signed.
You likely can't join if
- Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;
- Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);
- History of brain surgery;
- Severe depression with HRSD score ≥ 35;
- Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);
- Contraindications to CT or MRI scanning(claustrophobia, etc);
See the full eligibility criteria
- Adult subject (male or female, 18-75 years);
- 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;
- Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;
- Normal cognitive function with MMSE score ≥ 24;
- Informed consent signed.
- Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;
- Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);
- History of brain surgery;
- Severe depression with HRSD score ≥ 35;
- Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);
- Contraindications to CT or MRI scanning(claustrophobia, etc);
- pregnant or breastfeeding female, or has positive pregnancy test prior to randomization;
- Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.);
- Expected lifetime \< 12 months;
- Currently receiving an investigational drug or device;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.