Effects of MR-guided focused ultrasound subthalamotomy on non-motor and motor symptoms of Parkinson’s disease patients with motor fluctuations – a pilot study.
Phase 4
- Conditions
- G20Parkinson disease
- Registration Number
- DRKS00023540
- Lead Sponsor
- niversitätsklinikum Schleswig-Holstein, Campus Kiel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
1. diagnosis of PD according to MDS diagnosis criteria for = 4 years
2. disabling motor fluctuations despite optimized medical treatment
3. a levodopa response of = 30% in the standardized levodopa-test
4. tremor of any type
Exclusion Criteria
1. neurosurgical contraindications (e.g. brain atrophy, history of abnormal bleeding, cerebro-vascular and cerebro- inflammatory disease)
2. standard MRI-contraindications such as non-MRI compatible implanted metallic devices including cardiac pacemakers
3. severe depression, dementia or unstable psychiatric disease
4. general contraindications (e.g. unstable cardiac status or arterial hypertension, substance abuse)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effects on non-motor and motor symptoms in PD. All endpoints will be exploratory.
- Secondary Outcome Measures
Name Time Method Effects on non-motor and motor symptoms in PD. All endpoints will be exploratory (for detailed description see study protocol).