Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505460
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Exploring the Possible Beneficial Impact of Non-invasive and Invasive Neuromodulation on Freezing of Gait in Parkinsons Disease During Different Ambulatory Complexities An Electrophysiological and fMRI Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploring the Possible Beneficial Impact of Non-invasive and Invasive Neuromodulation on Freezing of Gait in Parkinsons Disease During Different Ambulatory Complexities An Electrophysiological and fMRI Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Freezing of gait FOG stands out as a devastating symptom of Parkinsons disease PD where patients may become momentarily glued to the ground rendering them incapable of walking efficiently The pathogenesis of FOG remains uncertain but is likely attributed to functional perturbations in superficial cortical and deep locomotion regions FOG tends to manifest more prominently during complex walking such as turning than during simple straight forward walking and the reasons for this phenomenon remain unclear Unfortunately effective methods for overcoming this ambulatory issue has yet to be identified and quantifying paroxysmal gait spells proves challenging with clinical rating alone thus a scientific tool is warranted In this 3-year proposal the investigators plan to address these challenges comprehensively
Detailed Description:
First the investigators aim to develop an artificial intelligence algorithm for the identification and quantification of FOG episodes using Red-Green-Blue RGB and walkway pressure data PD patients experiencing FOG will undergo a standardized walking protocol on the PKMAS System acquiring simultaneous data from two angles of video recording and foot pressure Labeled videos of FOG incidents will be inputted into an algorithm Adaptive Fusion Algorithm for Spam Detection AFSD utilizing raw RGB data optical flow data DualTVL and their combination for temporal segmentation
Second the investigators intend to pinpoint sources of FOG in PD patients through electrophysiological methods during unconstrained walking employing a high-density 64-channel electroencephalographic ambulatory recording and motor imagery fMRI to delve into the pathophysiology of FOG under different ambulatory conditions Effective connectivity among higher neural regions including the basal ganglia cerebellum and cortical regions will be explored The resulting connectivity map will be overlaid with electric recording data to examine neurovascular coupling or uncoupling
Third the investigators plan to conduct non-invasive interventions transcranial direct current stimulation tDCS magnetic resonance-guided focused ultrasound MRgFUS and Deep Brain Stimulation DBS to assess their impact on gait and FOG in PD patients Motor imagery fMRI and electrophysiological investigations will be performed before and after treatment using the mentioned methods Our multi-modal approach aims to unravel the complexities of FOG in PD patients providing valuable insights and potentially benefiting those enduring the challenges posed by this debilitating symptom
Second the investigators intend to pinpoint sources of FOG in PD patients through electrophysiological methods during unconstrained walking employing a high-density 64-channel electroencephalographic ambulatory recording and motor imagery fMRI to delve into the pathophysiology of FOG under different ambulatory conditions Effective connectivity among higher neural regions including the basal ganglia cerebellum and cortical regions will be explored The resulting connectivity map will be overlaid with electric recording data to examine neurovascular coupling or uncoupling
Third the investigators plan to conduct non-invasive interventions transcranial direct current stimulation tDCS magnetic resonance-guided focused ultrasound MRgFUS and Deep Brain Stimulation DBS to assess their impact on gait and FOG in PD patients Motor imagery fMRI and electrophysiological investigations will be performed before and after treatment using the mentioned methods Our multi-modal approach aims to unravel the complexities of FOG in PD patients providing valuable insights and potentially benefiting those enduring the challenges posed by this debilitating symptom
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None