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Deep brain stimulation · 2 trials · 2 indications
The composite 'axial score' is built by 8 items from the UPDRS II and III, all 5-point rated (0 to 4) representing increasing levels of pathology. The 'axial score' will be scored by the sum of the ratings across the 8 items (Range 0 to 32). As change in UPDRS scores is a common primary efficacy outcome measure in Parkinson's disease and only items of the original UPDRS are required for the definition of the primary endpoint, the statistical evaluation methods should be based on the psychometric validation of the UPDRS and no own validation studies are necessary. Safety: falls
| Arm | Type | Description |
|---|---|---|
| 2 | SHAM_COMPARATOR | Sham-stimulation |
| 1 | ACTIVE_COMPARATOR | Active GPI-DBS |
| [STNmono] | ACTIVE_COMPARATOR | Conventional stimulation on subthalamic contacts |
| [STN+SNr] | EXPERIMENTAL | Combined subthalamic and nigral stimulation |
| Name | Type | Description |
|---|---|---|
| Deep brain stimulation (DBS) | DEVICE | Bilateral pallidal stimulation with an implanted DBS device |
| deep brain stimulation (ACTIVA PC, Medtronic) | DEVICE | High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude) |
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.