Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Deep brain stimulation · 1 trial · 1 indication
| 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...
Deep brain stimulation is used to treat medically refractory primary cervical dystonia, a neurological condition causing abnormal neck muscle contractions. It involves bilateral pallidal stimulation, targeting the globus pallidus internus region of the brain to modulate abnormal neural activity. The therapy is delivered via an implanted device and is intended for patients who have not responded adequately to medication.
Medtronic plc, traded as MDT on the New York Stock Exchange, develops deep brain stimulation for cervical dystonia. The company is conducting clinical research on this therapy, which is currently in Phase 3 development for this indication. Medtronic is a medical device company specializing in implantable technologies for neurological and other chronic conditions.
Deep brain stimulation is in Phase 3 clinical development for cervical dystonia. This stage involves late-stage testing to confirm efficacy and safety in a larger patient population. The therapy is investigational for this indication and has not yet been approved by regulatory authorities. A completed Phase 3 trial has been conducted to evaluate its effects.
Deep brain stimulation has one completed Phase 3 clinical trial, identified as NCT00148889. This double-blind, multicenter study assessed the efficacy of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia. The trial enrolled 63 participants across Austria and Germany, with an active-controlled design and randomization. It included adults aged 18 years and older.
Deep brain stimulation for cervical dystonia is delivered as bilateral pallidal stimulation, meaning the therapy targets the globus pallidus internus region of the brain. In this context, pallidal stimulation is a specific form of deep brain stimulation. The clinical trial NCT00148889 specifically evaluated bilateral pallidal stimulation as the intervention for this condition.