Cereneo
Vitznau, Canton of Lucerne, 6354, Switzerland
Location status: Recruiting
Location contact
Andreas Luft, Professor
CONTACT
Lena Salzmann, PhD student
CONTACT
NCT Number: NCT05820074
This observational study's main goal is to learn more about the neural mechanisms during movement in Parkinson's disease. Furthermore, it aims to inspire personalised treatment options.
Participants will undergo a protocol that involves walking and gait-related motor tasks, such as seated stepping. During the protocol, brain activity will be recorded.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Vitznau, Canton of Lucerne, 6354, Switzerland
Location status: Recruiting
Andreas Luft, Professor
CONTACT
Lena Salzmann, PhD student
CONTACT
Parkinson's Disease (PD) is the second most common neurodegenerative disease accompanied by motor impairment [1]. Although symptomatic treatments like medication with Dopamine equivalents and deep brain stimulation (DBS) are available, the effects are very heterogeneous among patients and often cease over time.
This study aims to generate insights into the neural mechanisms of PD by determining neural biomarkers for gait. The insights of this study may further inspire personalised treatment approaches.
The primary objective is to identify neural biomarkers for gait. It is hypothesised that characteristic neural oscillations are underlying kinematic patterns in healthy participants and PD patients.
The secondary objective is to compare the neural activity during gait and a seated lower limb motor task between healthy participants and PD patients. To this end, the investigators hypothesise that neural correlates of gait and of a seated lower limb motor task differ between healthy participants and PD patients.
60 participants will be included, 30 healthy participants and 30 PD patients. All participants must be older than 18 years and give informed consent. Potential participants will be pre-screened and will be informed about the study via phone call/email. Before any study procedure, participants will give informed consent as documented by signature. Afterwards, inclusion/exclusion criteria, medical history and participant characteristics will be assessed. PD patients must be of postural instability and gait difficulty sub-type.
The study consists of one session of approximately 2.5 hours. During this session, electroencephalography (EEG) in healthy participants and EEG + local field potentials of the subthalamic nucleus from implanted DBS-electrodes in PD patients will be recorded during standardised gait sequences and a seated lower limb motor task. Furthermore, a short-term neuromodulation task will be investigated.
Gait-related parameters will be recorded using motion capture, surface electromyography (EMG) and accelerometers. Gait characteristics, including symmetry, coordination, variability, and resilience will be assessed. All recording devices are approved on the market. The protocol of the session slightly differs between healthy participants and PD patients since no DBS electrodes are implanted in healthy participants, but still allows for comparison between the groups.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants
Healthy control group
Parkinson's Patients
Exclusion criteria
Neural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded.
Other names: Electroencephalography (EEG), Local-Field-Potentials with deep brain stimulation electrodes
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
Other names: Motion capture, Accelerometers, Electromyography
Neural signals are recorded with the electrodes of the deep brain stimulation device. Parkinson's patients are asked to modulate their neural activity by observing the streamed neural activity and applying mental strategies.
Time frame: 30 minutes
Using a mobile EEG system to measure neural activity during walking
Time frame: 30 minutes
Electrodes will be attached to a representative lower limb muscle, such as the tibialis anterior.
Time frame: 30 minutes
ZurichMOVE® detects onset of movements
Time frame: 30 minutes
Neural activity between healthy controls and partient cohort will be compared.
Time frame: 15 minutes
Analysing the difference between healthy subjects and PD patients
Time frame: 15 minutes
Analysing the difference between healthy subjects and PD patients
Contact information is provided by the study sponsor or research team.
Lena Salzmann, MSc
CONTACT
Olivier Lambercy, PhD
CONTACT
Swiss Federal Institute of Technology
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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