G20
Conditions
Interventions
Group 1: anatomy-based continuous deep brain stimulation (aicDBS)
Group 2: adaptive deep brain stimulation (aDBS)
Sponsors
Universitätsklinikum Köln, Klinik und Poliklinik für Neurologie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinically established diagnosis of Parkinson’s disease Bilateral implantation of directional electrodes for deep brain stimulation in the subthalamic nucleus at least 10 weeks prior to study start Stimulation system capable of adaptive stimulation (Medtronic Percept RC/PC) Oral and written informed consent Stable Parkinson’s disease–specific medication for at least two weeks prior to study start
Exclusion criteria
Exclusion criteria: Clinically relevant cognitive impairment Levodopa dysregulation syndrome Severe affective disorder Inability or unwillingness to independently switch stimulation programs using the patient controller Insufficient image quality of perioperative clinical imaging (cMRI/cCT) for reconstruction of the individual electrode position
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective preference of patients between anatomy-based stimulation (aicDBS) and adaptive stimulation (aDBS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapy-associated changes in motor and non-motor symptoms assessed by questionnaires and continuous accelerometry, as well as electrophysiological data recorded via the deep brain stimulation electrode | — |
Countries
Germany
Contacts
Public ContactMichael Thomas Barbe
Universitätsklinikum Köln, Klinik und Poliklinik für Neurologie
Outcome results
None listed