Clinical trial NCT05820074: Investigating Neural Biomarkers for Gait in Parkinson's Patients
Official title: Investigating Neural Biomarkers for Gait in Parkinson's Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Keywords: Parkinson's disease
gait parameters
neural activity
Percept PC
deep brain stimulation
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: cereneo center for Neurology and Rehabilitation
name: University of Zurich
First posted: 2023-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited among students, employees and associated persons of ETH Zürich, the University of Zürich, the University Hospital of Zürich, and Balgrist University Hospital and other centers.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cortical activity underlying kinematic gait patterns will be recorded by electroencephalograph of the healthy and Parkinson patients
timeFrame: 30 minutes
measure: Electromyography (Delsys®) of the healthy and Parkinson patients
timeFrame: 30 minutes
measure: 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
timeFrame: 30 minutes
Secondary outcomes:
measure: Compare cortical activity between healthy subjects and parkinson patients
timeFrame: 30 minutes
Other outcomes:
measure: Difference in movement frequency between healthy participants and PD patients
timeFrame: 15 minutes
measure: Difference in the range of motion between healthy participants and PD patients
timeFrame: 15 minutes
Locations:
city: Vitznau
country: Switzerland
facility: Cereneo
state: Luzern
Study officials:
affiliation: RELab, ETH Zürich
name: Olivier Lambercy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.