Investigating Neural Biomarkers for Gait in Parkinson's Patients

November 28, 2024 updated by: Swiss Federal Institute of Technology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: 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.
Other Names:
  • Electroencephalography (EEG)
  • Local-Field-Potentials with deep brain stimulation electrodes
Diagnostic test: Movement Parameter Recording
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
Other Names:
  • Electromyography
  • Motion capture
  • Accelerometers
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.
Diagnostic test: 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.
Other Names:
  • Electroencephalography (EEG)
  • Local-Field-Potentials with deep brain stimulation electrodes
Diagnostic test: Movement Parameter Recording
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
Other Names:
  • Electromyography
  • Motion capture
  • Accelerometers
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.
Diagnostic test: 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.
Other Names:
  • Electroencephalography (EEG)
  • Local-Field-Potentials with deep brain stimulation electrodes
Diagnostic test: Movement Parameter Recording
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
Other Names:
  • Electromyography
  • Motion capture
  • Accelerometers
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 minutes
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.
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
Time Frame: 30 minutes
ZurichMOVE® detects onset of movements
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare cortical activity between healthy subjects and parkinson patients
Time Frame: 30 minutes
Neural activity between healthy controls and partient cohort will be compared.
30 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in movement frequency between healthy participants and PD patients
Time Frame: 15 minutes
Analysing the difference between healthy subjects and PD patients
15 minutes
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
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Zurich
cereneo center for Neurology and Rehabilitation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Lambercy, PhD, RELab, ETH Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-01382 NGB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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