Investigating Neural Biomarkers for Gait in Parkinson's Patients

NCT05820074 | Recruiting

• 1 other identifier: 2022-01382 NGB
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

Parkinson's disease; gait parameters; neural activity; Percept PC; deep brain stimulation

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  30 minutes

Secondary Outcomes (1)

• Compare cortical activity between healthy subjects and parkinson patients

  30 minutes

Other Outcomes (2)

• Difference in movement frequency between healthy participants and PD patients

  15 minutes

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

  15 minutes

Study Arms (3)

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; 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.

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.

Diagnostic Test: Neural Activity Recording; Diagnostic Test: Movement Parameter Recording; Other: Neuromodulation

Interventions

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.

Also known as: Electroencephalography (EEG), Local-Field-Potentials with deep brain stimulation electrodes

Age-matched healthy control; Parkinson's patients; Young, healthy control

Movement Parameter Recording DIAGNOSTIC_TEST

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

Also known as: Motion capture, Accelerometers, Electromyography

Age-matched healthy control; Parkinson's patients; Young, healthy control

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.

Parkinson's patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• cereneo center for Neurology and Rehabilitation: collaborator
• University of Zurich: collaborator

Study Sites (1)

Cereneo

Vitznau, Canton of Lucerne, 6354, Switzerland

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Interventions

Electroencephalography; Motion Capture; Electromyography; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Diagnostic Tests, Routine; Investigative Techniques; Myography; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Olivier Lambercy, PhD

  RELab, ETH Zürich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Salzmann, MSc

CONTACT

+41788248679; lena.salzmann@hest.ethz.ch

Olivier Lambercy, PhD

CONTACT

oliver.lambercy@hest.ethz.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: April 19, 2023
• Study Start: April 13, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CH (1)