Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00148889 | Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia | PHASE3 | COMPLETED | 63 | — | — | Jul 1, 2005 | Apr 1, 2008 | Feb 19, 2018 | 10 | Austria, Germany |
| Arm | Type | Description |
|---|---|---|
| 2 | SHAM_COMPARATOR | Sham-stimulation |
| 1 | ACTIVE_COMPARATOR | Active GPI-DBS |
| Name | Type | Description |
|---|---|---|
| Deep brain stimulation (DBS) | DEVICE | Bilateral pallidal stimulation with an implanted DBS device |
Inclusion Criteria: * Primary cervical dystonia * Disease duration 3 years or longer * Adult patient (18 years or older) * TWSTRS severity score 15 or more * Non-response to Botulinum Toxin * Non-response to oral antidystonic medication * Informed consent Exclusion Criteria: * Dementia (Mattis De...