Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05820074
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2022-12-13
Brief Title:
Investigating Neural Biomarkers for Gait in Parkinsons Patients
Sponsor:
Swiss Federal Institute of Technology
Organization:
Swiss Federal Institute of Technology
Study Overview
Official Title:
Investigating Neural Biomarkers for Gait in Parkinsons Patients
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational studys main goal is to learn more about the neural mechanisms during movement in Parkinsons 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
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:
Parkinsons 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 callemail Before any study procedure participants will give informed consent as documented by signature Afterwards inclusionexclusion 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 25 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
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 callemail Before any study procedure participants will give informed consent as documented by signature Afterwards inclusionexclusion 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 25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None