Directional Stimulation in Parkinson’s Disease
- Conditions
- G20Parkinson disease
- Registration Number
- DRKS00010783
- Lead Sponsor
- niversitätsklinikum FreiburgKlinik für NeurochirurgieAbteilung für Steroetaktische und Funktionelle Neurochirurgie
- Brief Summary
The study was terminated prematurely and will not be evaluated. The reason is that the measurements to be carried out within the local surgical routine have proven to be too complex and therefore not feasible. In this respect, the feasibility of the approach to be tested in the validation phase has not been confirmed and the second, randomized phase of the study could not be started. Five patients were included in the study. Evaluable electrophysiological data could only be obtained from one of the five patients. A final report will not be created due to the early termination and the small amount of analyzable data.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 5
1. Male or female patients aged =35 and = 75 years
2. Patients with the diagnosis of Parkinson’s disease according to the criteria of the British PD Brain Bank. Parkinson patients are included with a prominent hypokinetic-rigid component of their disease and beginning or severe motor fluctuations
3. Disease duration = 4 years
4. Written informed consent
5. UPDRS part III (off) 30-50
1. Major Depression with suicidal thoughts or suicidal thoughts in history
2. Signs of dementia in neuropsychological testing (part of clinical routine assessment)
3. Acute psychosis stated by a psychiatric physician
4. Nursing care at home
5. Unable to give written informed consent
6. Surgical contraindications
7. Medications that are likely to cause interactions in the opinion of the investigator
8. Known or persistent abuse of medication, drugs or alcohol
9. Current or planned pregnancy, nursing period
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapeutic width of a directed current paradigm compared to a conventional (spherical”) stimulation
- Secondary Outcome Measures
Name Time Method -Therapeutic widths of directed current paradigms (conventional (spherical”) mode stimulation, stimulation based on a computational model of an optimal electric field, electrophysiology-based stimulation paradigm).<br>-Unified Parkinson’s Disease rating scale (UPDRS) Part III (Stim On, Med Off) immediately after programming of the DBS-System. For this assessment, an amplitude will be selected that is just below the threshold of side effects (including On-state dyskinesia).<br>-UPDRS Part III (Stim On, Med. On) after 4 weeks for each paradigm (spherical mode stimulation, modulation of the electric field based on a computational model, modulation of the electric field based on intraoperative electrophysiological measurements) <br>-Description of side effects