ESSENTIAL TREMOR Parkinson's Disease
Conditions
Interventions
Group 1: Clinical determination of the most efficient contact for contralateral tremor suppression.
Group 2: Imaging-based determination of the most efficient contact for contralateral tremor suppress
Sponsors
Universität zu KölnZentrum für Klinische Studien
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male, female, or diverse patients aged = 18 Jahren and = 80 years. 2. Confirmed diagnosis of Parkinson’s Disease or Essential Tremor. Patients with Parkinson’s Disease must have a relevant tremor burden defined as = 2 of 4 points of the item 20 (rest tremor) as measured by the Unified Parkinson’s Disease rating scale without medication. 3. Uni- or bilateral implantation of DBS leads in the subthalamic nucleus (PD) or the ventral intermedius nucleus of the thalamus and the posterior subthalamic area (ET) at least 3 months prior to study inclusion. 4. Availability of imaging data for lead reconstruction and individual fiber tracking (preoperative MRI, preoperative diffusion tensor imaging, postoperative CT or MRI). 5. Patients must be able to consent to participate at the study and to give written informed consent prior to study inclusion.
Exclusion criteria
Exclusion criteria: Non-fullfillment of inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target point-wise non-inferiortiy of clinically determined tremor control as achieved by the most effective contact determined by clinical testing Arm 1) and the most effective contact as determined by the imaging-based analysis (Arm 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of determination of the most effective contact per Study Arm - Non-Inferiority of tremor control regarding tremor at rest, intention, and postural tremor - Side-effect tresholds of the respective most efficient contacts - maximum tremor control achievable by the respective most efficient contact - combined analysis of both target points (STN and VIM/PSA) for all outcome parameters | — |
Countries
Germany
Contacts
Public ContactJan Niklas Petry-Schmelzer
Universitätsklinikum KölnKlinik und Poliklinik für Neurologie
Outcome results
None listed