Brief Title
Brain Network Activation in Patients With Movement Disorders
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
Brief 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
Detailed 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.
Study Type
Observational
Primary Outcome
MDS-UPDRS part III score
Secondary Outcome
International Cooperative Ataxia Rating Scale
Condition
Parkinson Disease
Study Arms / Comparison Groups
Parkinson;s Disease
Description: Patients will undergo EEG recordings at rest and while performing the set of motor and cognitive tasks and BNA analysis. Additionally patients will be rated using MoCA, FAB, Verbal Fluency, - Beck Depression Inventory, PDQ-39, PD sleep scale (PDSS), MDS-UPDRS.SF-EMG and KinesiaOne and motion sensor assessment for tremor.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
300
Start Date
March 1, 2019
Completion Date
September 15, 2022
Primary Completion Date
December 15, 2021
Eligibility Criteria
Inclusion Criteria:
- For PD: Idiopathic PD patients (according to the UK PD Society brain bank clinical
diagnostic criteria (bradykinesia plus at least one other cardinal feature of PD, no
atypical features or secondary cause).
- For ET: bilateral, largely symmetrical postural or kinetic tremor involving hand and
forearms that is visible and persistent. Additional or isolated tremor of the head may
occur but in the absence of abnormal posturing.
- For Parkinson plus syndrome: multiple system atrophy (MSA), progressive supranuclear
palsy (PSP), corticobasal degeneration (CBD) and dementia with Lewy bodies (DLB).
- For NPH: patients exhibiting some or all components of the clinical triad consisting
of gait disturbance, urinary control disturbance and cognitive impairment as well as
proof of enlarged ventricular system or hydrocephalus by cranial CT or MRI scans.
- For Dystonia: patients exhibiting a movement disorder syndrome in which sustained or
repetitive muscle contractions result in twisting and repetitive movements or abnormal
fixed postures. The movements may resemble a tremor. Patients included will be those
with either idiopathic, toxic or hereditary mechanism.
- For Cerebellar ataxia: patients exhibiting impairment of coordination and balance as
part of an ataxic cerebellar syndrome which is caused by degeneration of the
cerebellum and its afferent and efferent connections due to various etiologies, such
as genetic or sporadic neurodegenerative processes or others.
Exclusion Criteria:
- In the investigator's opinion, any unstable or clinically significant condition that
would impair the participants' ability to comply with study requirements.
- Patients with significant psychiatric symptoms or history or treatment with
neuroleptics.
- MMSE <10
- Currently with lice or open wounds on scalp.
- Significant sensory deficits, e.g., deafness or blindness
- Current drug abuse or alcoholism.
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT03269201
Organization ID
4408-17
Responsible Party
Principal Investigator
Study Sponsor
Sheba Medical Center
Study Sponsor
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Verification Date
March 2021