G20
Conditions
Interventions
Group 1: Deep brain stimulation with a pulse width of 30µs for 4 weeks, followed by a deep brain stimulation with 60µs for 4 weeks.
Group 2: Deep brain stimulation with a pulse width of 60µs for 4 wee
Sponsors
Klinik und Poliklinik für Neurologie der Universitätskliniken zu Köln
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Bilateral Implantation of electrodes for deep brain stimulation of the subthalamic nucleus for the treatment of idiopathic Parkinson's disease: a. at least 3 months prior to study participation b. the implanted pulse generator enables a pulse width of 30µs per clinical routine (Boston Scientific Vercise, Vercise PC and Gevia; Abbott Medical Infinity DBS System 2. The patient is not allowed to participate at another studies during which an adjustment of medication or stimulation parameters is needed at the same time 3. Patients need to agree with video and voice recordings and sign a patient consent form
Exclusion criteria
Exclusion criteria: Inclusion criteria not completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Motor Diary during the last three days before the next follow-up visit after 4 weeks of deep brain stimulation with one of the two pulse widths (30µs or 60µs) - co-primary endpoint: Unified Parkinson's disease rating scale in MedOFF/StimON at follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| After four weeks of deep brain stimulation with one of the two pulse widths respectively (30µs or 60µs): - energy consumption - Parkinson's disease Questionnaire 39 - Non-motor symptom scale, Non-motor symptoms questionnaire - reading of a German standard text additionally: - preferred setting after finishing the study | — |
Countries
Germany
Contacts
Public ContactJan Niklas Petry-Schmelzer
Universitätskliniken Köln Klinik und Poliklinik für Neurologie
Outcome results
None listed