G20
Conditions
Interventions
Group 1: Patients with a diagnosis of clinically probable or established Parkinson's disease according to the criteria of the Movement Disorder Society and implantation of directional electrodes for d
Sponsors
Universitätsklinikum Marburg, Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a clinical diagnosis of Parkinson’s disease according to the clinical criteria of the Movement Disorders Society (Postuma et al. 2015) and implantation of directional DBS electrodes in the area of the subthalamic nucleus at least three months ago (electrodes: Boston Scientific directional leads BS-2202, Vercise DBS System). 2. Ability to provide informed consent, allowing a written declaration of consent. 3. Performance of a clinical assessment to determine the optimal stimulation setting (routinely conducted in the Department of Neurology three months after electrode implantation).
Exclusion criteria
Exclusion criteria: 1. Individuals who are legally incapacitated, minors, or persons institutionalized by court or administrative order. 2. Patients whose condition leads to severe gait impairment with loss of independent walking ability, requiring assistive devices such as a walking stick, walker, or wheelchair, or experiencing frequent falls (>2 falls in the past 30 days). 3. Patients with Parkinson’s disease who also suffer from another neurological disorder (e.g., epilepsy, Alzheimer’s disease, dystonia, etc.). 4. Presence of life-threatening or severe psychiatric illnesses. 5. Hearing or vision impairments that significantly hinder testing. 6. Pregnant or breastfeeding mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the change in walking speed and stride length during different localisation of stimulation volumes under low-frequency DBS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor symptoms, cognitive performance, freezing of gait and impulsivity are evaluated as part of the baseline test, after the image-guided stimulation setting and after four weeks and six months. These are assessed using the Movement Disorder Society-Unified Parkinson's disease Rating Scale (MDS-UPDRS), Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP), Berg Balance Scale (BBS), Freezing of Gait Questionnaire (FOGQ), Montreal Cognitive Assessment (MOCA) | — |
Countries
Germany
Contacts
Public ContactDavid Pedrosa
Universitätsklinikum Marburg, Klinik für Neurologie
Outcome results
None listed