Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

Deep Brain Stimulation Clinical Trial

— MEIGES  

Official title:

Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416905
• Other study ID #: HX-A-2022022
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: Beijing Tiantan Hospital
• Contact: Yutong Bai, MD, PhD
• Phone: 13611420134
• Email: baiyutong88[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Dystonia
• Dystonic Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Pins Medical Co., Ltd, Chinese PLA General Hospital, Civil Aviation General Hospital, Peking Union Medical College Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	365 days postoperatively compared between groups
Secondary	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.	90 days postoperatively compared between groups
Secondary	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.	180 days postoperatively compared between groups]
Secondary	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.	365 days postoperatively compared between groups
Secondary	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.	365 days postoperatively compared between groups
Secondary	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.	365 days postoperatively compared between groups
Secondary	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.	365 days postoperatively compared between groups
Secondary	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.	365 days postoperatively compared between groups
Secondary	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.	365 days postoperatively compared between groups
Secondary	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.	365 days postoperatively compared between groups
Secondary	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.	365 days postoperatively compared between groups
Secondary	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.	365 days postoperatively compared between groups