Investigating Neural Biomarkers for Gait in Parkinson's Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.
• Диагностический тест Movement Parameter Recording
  Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
• Другое 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.

Первичные конечные точки

• Cortical activity underlying kinematic gait patterns will be recorded by electroencephalograph of the healthy and Parkinson patients [Срок оценки: 30 minutes]
• Electromyography (Delsys®) of the healthy and Parkinson patients [Срок оценки: 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 [Срок оценки: 30 minutes]

Вторичные конечные точки (1)

• Compare cortical activity between healthy subjects and parkinson patients [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Швейцария · 1 центр

• Cereneo — Vitznau

Публикации

• 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. PMID 28332488
• 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. PMID 31639377
• 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. PMID 23208668
• 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. PMID 33846456

Идентификаторы

NCT: NCT05820074 · 2022-01382 NGB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗