Prospective evaluation of determining the most effective contact for tremor control in patients with deep brain stimulation based on individual tractography
- Conditions
- ESSENTIAL TREMORParkinson's Disease
- Registration Number
- DRKS00026596
- Lead Sponsor
- niversität zu KölnZentrum für Klinische Studien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
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.
Non-fullfillment of inclusion criteria.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Duration of determination of the most effective contact per Study Arm<br>- Non-Inferiority of tremor control regarding tremor at rest, intention, and postural tremor<br>- Side-effect tresholds of the respective most efficient contacts<br>- maximum tremor control achievable by the respective most efficient contact<br>- combined analysis of both target points (STN and VIM/PSA) for all outcome parameters