Investigating Neural Biomarkers for Gait in Parkinson's Patients
NCT ID: NCT05820074
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2023-04-13
2025-03-31
Brief Summary
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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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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Young, healthy control
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.
Neural Activity Recording
Neural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded.
Movement Parameter Recording
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
Age-matched healthy control
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.
Neural Activity Recording
Neural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded.
Movement Parameter Recording
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
Parkinson's patients
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.
Neural Activity Recording
Neural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded.
Movement Parameter Recording
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
Neuromodulation
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.
Interventions
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Neural Activity Recording
Neural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded.
Movement Parameter Recording
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
Neuromodulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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cereneo center for Neurology and Rehabilitation
UNKNOWN
University of Zurich
OTHER
Swiss Federal Institute of Technology
OTHER
Responsible Party
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Principal Investigators
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Olivier Lambercy, PhD
Role: PRINCIPAL_INVESTIGATOR
RELab, ETH Zürich
Locations
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Cereneo
Vitznau, Canton of Lucerne, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Poewe W, Seppi K, Tanner CM, Halliday GM, Brundin P, Volkmann J, Schrag AE, Lang AE. Parkinson disease. Nat Rev Dis Primers. 2017 Mar 23;3:17013. doi: 10.1038/nrdp.2017.13.
Ravi DK, Gwerder M, Konig Ignasiak N, Baumann CR, Uhl M, van Dieen JH, Taylor WR, Singh NB. Revealing the optimal thresholds for movement performance: A systematic review and meta-analysis to benchmark pathological walking behaviour. Neurosci Biobehav Rev. 2020 Jan;108:24-33. doi: 10.1016/j.neubiorev.2019.10.008. Epub 2019 Oct 19.
Rodriguez-Oroz MC, Moro E, Krack P. Long-term outcomes of surgical therapies for Parkinson's disease. Mov Disord. 2012 Dec;27(14):1718-28. doi: 10.1002/mds.25214. Epub 2012 Dec 3.
Bichsel O, Stieglitz LH, Oertel MF, Baumann CR, Gassert R, Imbach LL. Deep brain electrical neurofeedback allows Parkinson patients to control pathological oscillations and quicken movements. Sci Rep. 2021 Apr 12;11(1):7973. doi: 10.1038/s41598-021-87031-2.
Other Identifiers
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2022-01382 NGB
Identifier Type: -
Identifier Source: org_study_id