Investigating Neural Biomarkers for Gait in Parkinson's Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigating Neural Biomarkers for Gait in Parkinson's Patients

Conditions
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Parkinson Disease, Gait Disorders, Neurologic

Intervention / Treatment
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* Diagnostic Test: Neural Activity Recording
* Diagnostic Test: Movement Parameter Recording
* Other: Neuromodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants must have given informed consent as documented by signature agree to comply with the study procedures Healthy control group no neurological, orthopedic, or rheumatologic disease history no identified sensory impairment. no epilepsy and self-diagnosed acute or chronic psychiatric disorders Parkinson's Patients non-tremor dominant idiopathic PD patients presence of postural instability (UPDRS >1 for postural instability [17]), gait disturbance, and absence of other causes of reduced balance Implanted with Percept™ PC neurostimulator Able to be in the stimulation OFF Exclusion Criteria: Relevant cognitive impairment, with a score on Montréal Cognitive Assessment (MoCA) < 20 History of physical or neurological condition that interferes with study procedures Social and/or personal circumstances interfering with the ability to come to the session

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Young, healthy control<br>Young healthy participants below 45 years will take part in a gait protocol involving treadmill walking with pertubations and overground walking including obstacle stepping, figure-8-walk and timed-up-and-go test, as well as a seated-stepping section. During the protocol, neural activity is recorded using EEG. | Diagnostic Test: Neural Activity Recording<br>* Neural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded.<br>* Other names: Local-Field-Potentials with deep brain stimulation electrodes;Diagnostic Test: Movement Parameter Recording<br>* Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.<br>* Other names: Electromyography;|
| Age-matched healthy control<br>Age-matched healthy participants above 45 years will take part in a gait protocol involving treadmill walking with pertubations and overground walking including obstacle stepping, figure-8-walk and timed-up-and-go test, as well as a seated-stepping section. During the protocol, neural activity is recorded using EEG. | Diagnostic Test: Neural Activity Recording<br>* Neural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded.<br>* Other names: Local-Field-Potentials with deep brain stimulation electrodes;Diagnostic Test: Movement Parameter Recording<br>* Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.<br>* Other names: Electromyography;|
| Parkinson's patients<br>Parkinson's patients will take part in a gait protocol involving treadmill walking with pertubations and overground walking including obstacle stepping, figure-8-walk and timed-up-and-go test, as well as a seated-stepping section. Additionally, a neuromodulation set-up will be tested. During the protocol, neural activity is recorded using EEG and signals from the DBS-electrodes. | Diagnostic Test: Neural Activity Recording<br>* Neural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded.<br>* Other names: Local-Field-Potentials with deep brain stimulation electrodes;Diagnostic Test: Movement Parameter Recording<br>* Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.<br>* Other names: Electromyography;Other: Neuromodulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical activity underlying kinematic gait patterns will be recorded by electroencephalograph of the healthy and Parkinson patients | Using a mobile EEG system to measure neural activity during walking | 30 minutes | 
| Electromyography (Delsys®) of the healthy and Parkinson patients | Electrodes will be attached to a representative lower limb muscle, such as the tibialis anterior. | 30 minutes | 
| Detect onset of task-related movements detected by an accelerometer that will be placed on the hand and foot of the healthy and the parkinson patients | ZurichMOVE® detects onset of movements | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare cortical activity between healthy subjects and parkinson patients | Neural activity between healthy controls and partient cohort will be compared. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, gait parameters, neural activity, Percept PC, deep brain stimulation