Short pulses in neurostimulation for Parkinson's Disease
- Conditions
- G20Parkinson disease
- Registration Number
- DRKS00017528
- Lead Sponsor
- Klinik und Poliklinik für Neurologie der Universitätskliniken zu Köln
- Brief Summary
Background: Subthalamic nucleus deep brain stimulation (STN-DBS) is a well-established treatment for patients with Parkinson’s disease. Previous acute challenge studies suggested that short pulse widths might increase the therapeutic window while maintaining motor symptom control with a decrease in energy consumption. However, only little is known about the effect of short pulse width stimulation beyond the setting of an acute challenge. Objective: To compare 4 weeks of STN-DBS with conventional pulse width stimulation (60 µs) to 4 weeks of STN-DBS with short pulse width stimulation (30 µs) regarding motor symptom control. Methods: This study was a monocentric, double-blinded, randomized crossover non-inferiority trial investigating whether short pulse width stimulation with 30 µs maintains equal motor control as conventional 60 µs stimulation over a period of 4 weeks (German Clinical Trials Register No. DRKS00017528). Primary outcome was the difference in motor symptom control as assessed by a motor diary. Secondary outcomes included energy consumption measures, non-motor effects, side-effects, and quality of life. Results: Due to a high dropout rate, the calculated sample size of 27 patients was not met and 24 patients with Parkinson’s disease and STN-DBS were included in the final analysis. However, there were no differences in any investigated outcome parameter between the two treatment conditions. Conclusion: This study demonstrates that short pulse width settings (30 µs) provide non-inferior motor symptom control as conventional (60 µs) stimulation without significant differences in energy consumption. Future studies are warranted to evaluate a potential benefit of short pulse width settings in patients with pronounced dyskinesia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
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
Inclusion criteria not completed.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - 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)<br>- co-primary endpoint: Unified Parkinson's disease rating scale in MedOFF/StimON at follow-up visit
- Secondary Outcome Measures
Name Time Method After four weeks of deep brain stimulation with one of the two pulse widths respectively (30µs or 60µs):<br>- energy consumption<br>- Parkinson's disease Questionnaire 39<br>- Non-motor symptom scale, Non-motor symptoms questionnaire<br>- reading of a German standard text<br><br>additionally:<br>- preferred setting after finishing the study