Brain Network Activation in Patients With Movement Disorders

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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


Primary Outcome

MDS-UPDRS part III score

Secondary Outcome

 International Cooperative Ataxia Rating Scale


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.


* 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


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

          -  MMSE <10

          -  Currently with lice or open wounds on scalp.

          -  Significant sensory deficits, e.g., deafness or blindness

          -  Current drug abuse or alcoholism.




18 Years - 85 Years

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Sheba Medical Center

Study Sponsor

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Verification Date

March 2021