Prospective, controlled study of deep brain stimulation (DBS) in the region of the posterior subthalamic area (PSA) with a randomized, double-blinded, cross-over comparison between PSA- and nucleus ventralis intermedius (VIM)-DBS for the treatment of essential tremor (ET).
Not Applicable
- Conditions
- G25.0Essential tremor
- Registration Number
- DRKS00004235
- Lead Sponsor
- niklinik Köln, Neurologie,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
i.) confirmed diagnosis of ET according to the Movement Disorder Society (MDS) consensus diagnostic criteria for ET
ii.) >18 years of age,
iii.) sufficient competence in the German language,
iv.) at least two medication attempts without satisfactory tremor control, and
v.) capability of informed consent.
Exclusion Criteria
i.) clinically relevant dementia that might interfere with the study,
ii.) clinically relevant psychiatric disorder that might interfere with the study,
iii.) surgical contraindication for bilateral DBS,
iv.) participation in another interventional trial,
v.) brain atrophy (i.e. width of 3rd ventricle > 10mm), and
vi.) pre- and perioperative intake of anticoagulative medication.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of the Fahn Tremor Rating Scale (FTRS) at 3, 5 and 7 months after implantation and stimulation by PSA-DBS com-pared to baseline<br><br>Please note: Amendment from 04.11.2014 regarding the timepoint of Assesment of primary Endpoint. Approved by the Ethics Commitee.
- Secondary Outcome Measures
Name Time Method - Baseline vs. 3, 5 and 7 MFU<br><br>Key secondary endpoint(s) PSA-DBS:<br>oImprovement of Quality of Life (SF-36, QUEST)<br>oDepression (BDI-II)<br>oAtaxia rating Scale (ICARS)<br>oVisual analogue scales – tremor/dysarthria/gait/general (physician)<br>oVisual analogue scales – tremor/dysarthria/gait/general (patient)<br><br><br>Key secondary endpoint(s) VIM/PSA comparison (cross-over):<br>oFahn Tremor Rating Scale (FTRS)<br>oQuality of Life (SF-36)<br>oDepression (BDI-II)<br>oAtaxia rating Scale (ICARS)<br>oSOFAS<br>oVisual analogue scales – tremor/dysarthria/gait/general (physician)<br>oVisual analogue scales – tremor/dysarthria/gait/general (patient)<br>oEffect and side effect thresholds<br>oAmount of current applied to the tissue<br>oOccurrence of AEs and SAEs<br><br>Assessment of safety:<br>oRegular clinical assessment<br>oEvaluation of adverse events and severe adverse events