G20
Conditions
Interventions
Group 1: Group A: Stimulation - Control
During clinical gait assessment adaptive, sensory electrical stimulation is applied to the lower leg by the M4P-System (Stimulation). Afterwards the gait assess
Sponsors
SensorStim Neurotechnology GmbH
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Only people who are legally competent and able to understand the goals, procedure and risks of the clinical study and who gave written informed consent to participate in the study. • Confirmed diagnose with ideopathic Parkinsons Syndrome • Sex/Age: Male patients between 40 – 85 years and women between 50 - 85 years who confirmed that they are postmenopausal • Manifested gait disorder with Freezing of Gait (FoG) smptoms (Freezing of Gait Questionnaire - Item 3: two or more points) • Able to walk at least 200 m
Exclusion criteria
Exclusion criteria: • People, who live in an institution due to official or judicial request. • People, who are clinical investigators or sponsor of the study or who are otherwise related to the clinical investigation site. • People, who have an active infection with SARS-CoV-2. • Motor symptoms caused by another neurological disease (e.g. Multiple Sklerosis, Stroke) • Open wounds, tumors, injuries or implants in the area of electrical stimulation (lower leg) • Impaired sensory perception of the legs (e.g. Polyneuropathy, spinal stenosis or nerve root compression) • Visible edema in the area of the lower legs • Dementia (MMST < 24 Points) • Epilepsy • All implanted electric stimulation devices, e.g. cardiac defibrillators or pacers, deep brain stimulation devices (DBS) • History of severe cardiac arrhythmias such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation with tachyarrhythmia absoluta). Stable patients with atrial fibrillation can be included in the study, if the cardiologist of the patient agrees. Atrial fibtillation is no contraindication for the use of the M4P-system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average trial time (in seconds) in the clinical gait assessment 'Freezing Assessment Course' | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurements of the clinical gait tests (10m-walking test and Freezing Assessment Course): • Time (in Sec) • Number of steps • Number of detected Freezing of Gait (FoG) steps • Number of stimulated steps • Duration of adaptive stimulation (in sec) • Duration of rhythmic stimulation (in sec) • Number of adaptive stimulation episodes • Number of rhythmic stimulation episodes • Objective gait parameters (measurements of the sensors) • Score of the Freezing Assessment Course • Questionnaire Usability (qualitative evaluation) • Questionnaire subjective usefulness (qualitative evaluation) | — |
Countries
Germany
Contacts
Public ContactNikolaus Wenger
Charité - Universitätsmedizin Berlin Klinik für Neurologie, Sektion Bewegungsstörungen
Outcome results
None listed