Parkinson DiseaseNCT05820074
Investigating Neural Biomarkers for Gait in Parkinson's Patients
An observational study of Parkinson Disease and Gait Disorders, Neurologic, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- Neural Activity Recording, Movement Parameter Recording and Neuromodulation
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Apr 2023to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Olivier Lambercy, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
Cereneo
Vitznau, Canton of Lucerne, 6354
Andreas Luft, Professor, +41 44 255 55 11, andreas.luft@usz.ch
Lena Salzmann, PhD student, +41 44 510 72 34, lena.salzmann@hest.ethz.ch
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- Neural Activity Recording, Movement Parameter Recording, Neuromodulation
- Keywords
- Parkinson's disease, gait parameters, neural activity, Percept PC, deep brain stimulation
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Activity RecordingDiagnostic test
Also called Electroencephalography (EEG), Local-Field-Potentials with deep brain stimulation electrodes
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 RecordingDiagnostic test
Also called Motion capture, Accelerometers, Electromyography
Gait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography.
NeuromodulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Neural Activity Recording; Diagnostic Test: Movement Parameter Recording | |
| 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. Receives: Diagnostic Test: Neural Activity Recording; Diagnostic Test: Movement Parameter Recording | |
| 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. Receives: Diagnostic Test: Neural Activity Recording; Diagnostic Test: Movement Parameter Recording; Other: Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical activity underlying kinematic gait patterns will be recorded by electroencephalograph of the healthy and Parkinson patients
Using a mobile EEG system to measure neural activity during walking
Measured: 30 minutes
Electromyography (Delsys®) of the healthy and Parkinson patients
Electrodes will be attached to a representative lower limb muscle, such as the tibialis anterior.
Measured: 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
ZurichMOVE® detects onset of movements
Measured: 30 minutes
Secondary outcomes (1)
Compare cortical activity between healthy subjects and parkinson patients
Neural activity between healthy controls and partient cohort will be compared.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start13 Apr 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- cereneo center for Neurology and Rehabilitation, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Olivier Lambercy, PhD, Principal investigator, RELab, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820074
- Sponsor's protocol ID
- 2022-01382 NGB
- Status last verified
- Nov 2024
- First submitted
- 13 Dec 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28332488Ravi 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.
PubMed 31639377Rodriguez-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.
PubMed 23208668Bichsel 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.
PubMed 33846456
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Neural Biomarkers for Gait in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05820074
- Acronym / sponsor ID
- 2022-01382 NGB
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- Parkinson's disease, gait parameters, neural activity, Percept PC, deep brain stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- cereneo center for Neurology and Rehabilitation, University of Zurich
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young, healthy control | – | Diagnostic Test: Neural Activity Recording, Diagnostic Test: Movement Parameter RecordingYoung 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. |
| Age-matched healthy control | – | Diagnostic Test: Neural Activity Recording, Diagnostic Test: Movement Parameter RecordingAge-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. |
| Parkinson's patients | – | Diagnostic Test: Neural Activity Recording, Diagnostic Test: Movement Parameter Recording, Other: NeuromodulationParkinson'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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural Activity RecordingAlso: Electroencephalography (EEG), Local-Field-Potentials with deep brain stimulation electrodesNeural Activity is measured using EEG in all groups. Additionally, in Parkinson's patients, local-field-potentials from deep brain stimulation electrodes are recorded. | Diagnostic test | Age-matched healthy control, Parkinson's patients, Young, healthy control |
| Movement Parameter RecordingAlso: Motion capture, Accelerometers, ElectromyographyGait-related movement parameters are non-invasively recorded using motion capture, accelerometers and electromyography. | Diagnostic test | Age-matched healthy control, Parkinson's patients, Young, healthy control |
| NeuromodulationNeural 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 | Parkinson's patients |
Primary outcome
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
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.
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
1 secondary outcome
Compare cortical activity between healthy subjects and parkinson patients
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 28332488Poewe 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.
- Background: PubMed 31639377Ravi 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.
- Background: PubMed 23208668Rodriguez-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.
- Background: PubMed 33846456Bichsel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier Lambercy, PhD contact
Olivier Lambercy, PhD principal investigator
RELab, ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Gait Disorders, Neurologic, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena Salzmann, MSc (+41788248679, lena.salzmann@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical activity underlying kinematic gait patterns will be recorded by electroencephalograph of the healthy and Parkinson patients (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820074, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.