Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Civil Aviation General Hospital | OTHER |
| Chinese PLA General Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STN-DBS | Experimental | The patients in this group will be treated with STN-DBS. |
|
| GPi-DBS | Active Comparator | The patients in this group will be treated with GPi-DBS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STN-DBS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yutong Bai, MD, PhD | Contact | 13611420134 | baiyutong88@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianguo Zhang, MD, PhD | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Beijing Pins Medical Co., Ltd | INDUSTRY |
| Shandong University of Traditional Chinese Medicine | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Beijing Fengtai Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
|
|
| GPi-DBS | Device | 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. |
|
|
| 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] |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |