Investigating Neural Biomarkers for Gait in Parkinson's Patients

Parkinson Disease Clinical Trial

Official title:

Investigating Neural Biomarkers for Gait in Parkinson's Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820074
• Other study ID #: 2022-01382 NGB
• Status: Recruiting
• Start date: April 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Swiss Federal Institute of Technology
• Contact: Lena Salzmann, MSc
• Phone: +41788248679
• Email: lena.salzmann[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. During the protocol, brain activity will be recorded.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Intervention

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

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.

Locations

Country	Name	City	State
Switzerland	Cereneo	Vitznau	Luzern

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	cereneo center for Neurology and Rehabilitation, University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in movement frequency between healthy participants and PD patients	Analysing the difference between healthy subjects and PD patients	15 minutes
Other	Difference in the range of motion between healthy participants and PD patients	Analysing the difference between healthy subjects and PD patients	15 minutes
Primary	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
Primary	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
Primary	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	Compare cortical activity between healthy subjects and parkinson patients	Neural activity between healthy controls and partient cohort will be compared.	30 minutes