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Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN (MEIGES)

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ClinicalTrials.gov Identifier: NCT05416905
Recruitment Status : Recruiting
First Posted : June 14, 2022
Last Update Posted : July 7, 2022
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Peking University People's Hospital
Civil Aviation General Hospital
Chinese PLA General Hospital
Beijing Pins Medical Co., Ltd
Information provided by (Responsible Party):
Jianguo Zhang, Beijing Tiantan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Craniofacial Dystonia Deep Brain Stimulation Device: STN-DBS Device: GPi-DBS Not Applicable

Detailed Description:

Evaluating therapeutic effects of GPi-DBS vs. STN-DBS on patients with idiopathic craniofacial dystonia: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The main purpose is to assess whether STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arm Intervention/treatment
Experimental: STN-DBS
The patients in this group will be treated with STN-DBS.
Device: 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.
Other Name: subthalamic necleus-deep brain stimulation

Active Comparator: GPi-DBS
The patients in this group will be treated with GPi-DBS.
Device: 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 Name: globus pallidus internus-deep brain stimulation




Primary Outcome Measures :
  1. Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365 [ Time Frame: 365 days postoperatively compared between groups ]
    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.


Secondary Outcome Measures :
  1. Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90 [ Time Frame: 90 days postoperatively compared between groups ]
    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.

  2. Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180 [ Time Frame: 180 days postoperatively compared between groups] ]
    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.

  3. Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference [ Time Frame: 365 days postoperatively compared between groups ]
    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.

  4. Blepharospasm disability index (BDSI) difference [ Time Frame: 365 days postoperatively compared between groups ]
    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.

  5. Jankovic rating scale (JRS) difference [ Time Frame: 365 days postoperatively compared between groups ]
    Differences between the two groups in the change of Jankovic rating scale (JRS) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. JRS contains 2 items of 0-8 and higher scores indicate a worse outcome.

  6. Mini-mental state examination (MMSE) difference [ Time Frame: 365 days postoperatively compared between groups ]
    Differences between the two groups in the change of mini-mental state examination (MMSE) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. MMSE contains 30 questions of 0-30 and higher scores indicate a better outcome.

  7. Montreal cognitive assessment (MoCA) difference [ Time Frame: 365 days postoperatively compared between groups ]
    Differences between the two groups in the change of Montreal cognitive assessment (MoCA) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. MoCA contains 8 modules of 0-30 and higher scores indicate a better outcome.

  8. Hamilton depression scale (HRSD) difference [ Time Frame: 365 days postoperatively compared between groups ]
    Differences between the two groups in the change of Hamilton depression scale (HRSD) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. HRSD contains 24 items of 24-77 and higher scores indicate a worse outcome.

  9. Hamilton anxiety scale (HAMA) difference [ Time Frame: 365 days postoperatively compared between groups ]
    Differences between the two groups in the change of Hamilton anxiety scale (HAMA) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. HAMA contains 14 items of 0-56 and higher scores indicate a worse outcome.

  10. Medical outcomes study shortform-36 (SF-36) difference [ Time Frame: 365 days postoperatively compared between groups ]
    Differences between the two groups in the change of medical outcomes study shortform-36 (SF-36) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. SF-36 contains 8 modules of 0-100 and higher scores indicate a better outcome.

  11. Programming parameters difference [ Time Frame: 365 days postoperatively compared between groups ]
    Differences between the two groups in programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment, including total electrical energy delivered (TEED), contact, voltage, pulse width and frequency.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult subject (male or female, 18-75 years);
  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:

  1. Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;
  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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05416905


Contacts
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Contact: Yutong Bai, MD, PhD 13611420134 baiyutong88@qq.com

Locations
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China
Beijing Tiantan Hospital Recruiting
Beijing, China
Contact: Jianguo Zhang, MD, PhD    +86-13601294613    zjguo73@126.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Peking Union Medical College Hospital
Peking University People's Hospital
Civil Aviation General Hospital
Chinese PLA General Hospital
Beijing Pins Medical Co., Ltd
Investigators
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Study Chair: Jianguo Zhang, MD, PhD Beijing Tiantan Hospital
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Responsible Party: Jianguo Zhang, Director of Department of Functional Neurosurgery, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT05416905    
Other Study ID Numbers: HX-A-2022022
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianguo Zhang, Beijing Tiantan Hospital:
Craniofacial Dystonia
Deep Brain Stimulation
Globus pallidus internus
Subthalamic nucleus
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases