Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
STN-DBS
DeviceThe 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
DeviceThe 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: STN-DBSExperimental treatment 1 intervention
Group B: GPi-DBSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.
Time frame
365 days postoperatively compared between groupsSecondary outcomes
1
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 90 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.
Time frame
90 days postoperatively compared between groups2
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 180 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.
Time frame
180 days postoperatively compared between groups]3
Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference
Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-D contains 7 items of 0-30 and higher scores indicate a worse outcome.
Time frame
365 days postoperatively compared between groups4
Blepharospasm disability index (BDSI) difference
Differences between the two groups in the change of Blepharospasm disability index (BDSI) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BDSI contains 6 items of 0-4 (average socre) and higher scores indicate a worse outcome.
Time frame
365 days postoperatively compared between groupsSponsors and contacts
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Beijing Tiantan Hospital
Lead sponsor
Peking Union Medical College Hospital
Collaborator
Peking University People's Hospital
Collaborator
Civil Aviation General Hospital
Collaborator
Chinese PLA General Hospital
Collaborator
Beijing Pins Medical Co., Ltd
Collaborator
Shandong University of Traditional Chinese Medicine
Collaborator
Qilu Hospital of Shandong University
Collaborator
Beijing Fengtai Hospital
Collaborator
Source ClinicalTrials.gov