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

Primary Purpose

Craniofacial Dystonia, Deep Brain Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
STN-DBS
GPi-DBS
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniofacial Dystonia focused on measuring Craniofacial Dystonia, Deep Brain Stimulation, Globus pallidus internus, Subthalamic nucleus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STN-DBS

GPi-DBS

Arm Description

The patients in this group will be treated with STN-DBS.

The patients in this group will be treated with GPi-DBS.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Jankovic rating scale (JRS) difference
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.
Mini-mental state examination (MMSE) difference
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.
Montreal cognitive assessment (MoCA) difference
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.
Hamilton depression scale (HRSD) difference
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.
Hamilton anxiety scale (HAMA) difference
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.
Medical outcomes study shortform-36 (SF-36) difference
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.
Programming parameters difference
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.

Full Information

First Posted
June 9, 2022
Last Updated
July 5, 2022
Sponsor
Beijing Tiantan Hospital
Collaborators
Peking Union Medical College Hospital, Peking University People's Hospital, Civil Aviation General Hospital, Chinese PLA General Hospital, Beijing Pins Medical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05416905
Brief Title
Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Acronym
MEIGES
Official Title
Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Peking Union Medical College Hospital, Peking University People's Hospital, Civil Aviation General Hospital, Chinese PLA General Hospital, Beijing Pins Medical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniofacial Dystonia, Deep Brain Stimulation
Keywords
Craniofacial Dystonia, Deep Brain Stimulation, Globus pallidus internus, Subthalamic nucleus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STN-DBS
Arm Type
Experimental
Arm Description
The patients in this group will be treated with STN-DBS.
Arm Title
GPi-DBS
Arm Type
Active Comparator
Arm Description
The patients in this group will be treated with GPi-DBS.
Intervention Type
Device
Intervention Name(s)
STN-DBS
Other Intervention Name(s)
subthalamic necleus-deep brain stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
GPi-DBS
Other Intervention Name(s)
globus pallidus internus-deep brain stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365
Description
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 groups
Secondary Outcome Measure Information:
Title
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90
Description
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 groups
Title
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180
Description
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]
Title
Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference
Description
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 groups
Title
Blepharospasm disability index (BDSI) difference
Description
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 groups
Title
Jankovic rating scale (JRS) difference
Description
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.
Time Frame
365 days postoperatively compared between groups
Title
Mini-mental state examination (MMSE) difference
Description
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.
Time Frame
365 days postoperatively compared between groups
Title
Montreal cognitive assessment (MoCA) difference
Description
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.
Time Frame
365 days postoperatively compared between groups
Title
Hamilton depression scale (HRSD) difference
Description
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.
Time Frame
365 days postoperatively compared between groups
Title
Hamilton anxiety scale (HAMA) difference
Description
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.
Time Frame
365 days postoperatively compared between groups
Title
Medical outcomes study shortform-36 (SF-36) difference
Description
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.
Time Frame
365 days postoperatively compared between groups
Title
Programming parameters difference
Description
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.
Time Frame
365 days postoperatively compared between groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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, etc.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yutong Bai, MD, PhD
Phone
13611420134
Email
baiyutong88@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianguo Zhang, MD, PhD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianguo Zhang, MD, PhD
Phone
+86-13601294613
Email
zjguo73@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

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