Brain Network Activation in Patients With Movement Disorders — BNA-MDi  

Parkinson Disease Clinical Trial

Official title: Mapping Functional Networks of Brain Activity (Brain Network Activation, BNA) Based on Analysis of Evoked Response Potential (ERP) EEG Signals in Patients With Movement Disorders

Status Enrolling by invitation

Clinical Trial Summary

The diagnosis and management of movement disorders, such as Parkinson's disease (PD), parkinson-plus syndromes (PPS), dystonia, essential tremor (ET), normal pressure hydrocephalus (NPH) and others is challenging given the lack of objective diagnostic and monitoring tools with high sensitivity and specificity. A cornerstone in research of neurological disorders manifesting as MDi is the investigation of neurophysiological changes as potential biomarkers that could help in diagnosis, monitoring disease progression and response to therapies. Such a neuro-marker that would overcome the major disadvantages of clinical questionnaires and rating scales (such as the Unified Parkinson's disease rating scale -UPDRS, for PD, The Essential Tremor Rating Assessment Scale -TETRAS, for ET and others), including low test-retest repeatability and subjective judgment of different raters, would have real impact on disease diagnosis and choice of interventions and monitoring of effects of novel therapeutics, including disease modifying therapies.

To address this, ElMindA has developed over the last decade a non-invasive, low-cost technology named Brain Network Activation (BNA), which is a new imaging approach that can detect changes in brain activity and functional connectivity. Results from proof-of concept studies on PD patients have demonstrated that: 1) PD patients exhibited a significant decrease in BNA scores relatively to healthy controls; 2) notable changes in functional network activity in correlation with different dopamine-agonist doses; 3) significant correlation between BNA score and the UPDRS). 4) BNA could also differentiate early PD from healthy controls

Clinical Trial Description

Objective: The primary aim of the current project is to assess the utility of the BNA as a quantitative, objective, neurophysiological marker for diagnosis and monitoring of the above most common MDi in man.

The secondary aim is to find predictive bio-types (electrophysiological fingerprint) of the above MDi and within these disorders identifying patients with high likelihood of developing: 1) psychiatric complications such as dopaminergic medication induced-impulse control disorder (ICD) for PD; 2) Depression; 3) Gait and balance Impairment; or 4) Cognitive deterioration, including (PD-MCI) or PD-dementia (PDD).

The technology: BNA technology is based on non-invasive recordings of multi-channel EEG event-related potentials (ERPs), and a comprehensive multi-dimensional analysis of such recordings, aimed at understanding and visualizing the network complexity (or Brain Networks Activation patterns) of brain function. BNA takes cognitive ERPs, a direct measure of neural activity associated with cognitive functions, to a new frontier, unparalleled by EEG, QEEG or ERP alone or by any other anatomic and functional brain imaging and evaluation tools. The BNA algorithms use innovative sets of signal processing, pattern recognition and machine learning techniques to seek and map activated neural pathways while patients are engaged in a cognitive task. The resulting BNA network patterns can aid clinicians with profiling of changes in functionality and/or dysfunctionality. BNA received an FDA clearance and a CE mark approval during 2014, and is commercially available in the US, with more than 20 active clinical and research sites focusing on numerous neurological and neuropsychological disorders. More than 30,000 data sets of functional brain networks of healthy subjects have been already collected and may serve as normative data for comparison. ;

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Corticobasal Degeneration
• Dementia With Lewy Bodies
• Dystonia
• Essential Tremor
• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Lewy Body Disease
• Movement Disorders
• Multiple System Atrophy
• Normal Pressure Hydrocephalus
• Parkinson Disease
• Progressive Supranuclear Palsy
• Shy-Drager Syndrome
• Supranuclear Palsy, Progressive
• Tremor

• NCT number: NCT03269201
• Study type: Observational
• Source: Sheba Medical Center
• Status: Enrolling by invitation
• Start date: March 1, 2019
• Completion date: September 15, 2022