Parkinson'
Conditions
Interventions
Novel programming method
Standard programming method
Sponsors
Department of Neurology, Juntendo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least six months and programming optimized according to standard of care with no changes to settings for at least four weeks. Diagnosis of bilateral idiopathic PD with the presence of bradykinesia. UPDRS subset 3 score of more than 25 in the pre operative meds off state. DBS must improve PD symptoms by more than 30% in the meds off state, as measured by UPDRS subset 3 score. Willing and able to comply with all visits, including required travel, and with study related procedures. Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Exclusion criteria
Exclusion criteria: Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator. Any current drug or alcohol abuse as determined by the investigator. Any history of recurrent or unprovoked seizures. Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival less than 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data collected will be used to further development of a closed loop programming algorithm and to build a better understanding of clinical responses to stimulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the amount of time to program and number of steps to program using the novel programming method as compared to the standard of care (SOC) programming method. Difference in UPDRS-III scores obtained from novel method settings versus from SOC settings. | — |
Countries
Japan
Contacts
Public ContactSasaki Fuyuko
Juntendo University Hospital Department of Neurology
Outcome results
None listed