G20
Conditions
Interventions
Group 1: Directional stimulation, clinically effective stimulation amplitude (max 5mA), pulse width 60µs, frequency 130Hz, 1 day duration
Group 2: Classic stimulation, clinically effective stimulation
Sponsors
Universitätsklinikum Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis of primary parkinsonism 2. Bilateral implantation of directional DBS electrodes inside the subthalamic nucleus 3. At least age 18 and ability to perform written informed consent 4. Written informed consent after written and oral information
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic window, defined as the difference between the stimulation amplitude threshold needed for effective suppression of the target symptom (rigidity, tremor or akinesia depending on the patient) and the side effect threshold for irreversible side effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor outcome quantified using UPDRS (Unified Parkinson's Disease Rating Scale) hemibodyscore and the UPDRS subitems for tremor, rigidity, upper limb kinesia. Documentation of stimulation-induced side effects, stimulation amplitud and energy consumption. All gathered at the end of the two Crossover-Conditions on Day 2 and 3 of the study. | — |
Countries
Germany
Contacts
Public ContactElfriede Stubbs
Klinik und Poliklinik für Neurologie, Uniklinik Köln
Outcome results
None listed