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NCT Number: NCT05820074

Investigating Neural Biomarkers for Gait in Parkinson's Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neural Activity Recording

Diagnostic Test

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

Movement Parameter Recording

Diagnostic Test

Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.

Other names: Motion capture, Accelerometers, Electromyography

Neuromodulation

Other

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.

Primary outcomes

  1. Cortical activity underlying kinematic gait patterns will be recorded by electroencephalograph of the healthy and Parkinson patients

    Time frame: 30 minutes

    Using a mobile EEG system to measure neural activity during walking

  2. Electromyography (Delsys®) of the healthy and Parkinson patients

    Time frame: 30 minutes

    Electrodes will be attached to a representative lower limb muscle, such as the tibialis anterior.

  3. 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

    Time frame: 30 minutes

    ZurichMOVE® detects onset of movements

Secondary outcomes

  1. Compare cortical activity between healthy subjects and parkinson patients

    Time frame: 30 minutes

    Neural activity between healthy controls and partient cohort will be compared.

Other outcomes

  1. Difference in movement frequency between healthy participants and PD patients

    Time frame: 15 minutes

    Analysing the difference between healthy subjects and PD patients

  2. Difference in the range of motion between healthy participants and PD patients

    Time frame: 15 minutes

    Analysing the difference between healthy subjects and PD patients

Study contacts

Contact information is provided by the study sponsor or research team.

Lena Salzmann, MSc

CONTACT

[email protected]

+41788248679

Olivier Lambercy, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • University of Zurich
  • cereneo center for Neurology and Rehabilitation

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2023
Registry last updated
Dec 3, 2024

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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