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Brain Network Activation in Patients With Movement Disorders (BNA-MDi)

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ClinicalTrials.gov Identifier: NCT03269201
Recruitment Status : Not yet recruiting
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Sharon Hassin, Sheba Medical Center

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


Condition or disease
Parkinson Disease Essential Tremor Dystonia Normal Pressure Hydrocephalus Cerebellar Ataxia Multiple System Atrophy Progressive Supranuclear Palsy Corticobasal Degeneration Dementia With Lewy Bodies

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
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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
Estimated Study Start Date : September 15, 2017
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2022


Group/Cohort
Parkinson;s Disease
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.
Essential tremor
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 mmse/ MoCA, Verbal Fluency, essential tremor rating assessment scale (TETRAS) clinical rating scale for tremor (CRST).SF-EMG and KinesiaOne and motion sensor assessment writing and drawing on digitizer, for tremor.
Multiple system atrophy
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.
Normal Pressure Hydrocephalus
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, - TIMED UP AND GO TASK (INSTRUMENTAL)
DYSTONIA-focal, generalized and others

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, 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.Fahn-Marsden Evaluation Scale for Dystonia

.SF-EMG and KinesiaOne and motion sensor assessment , writing and drawing on digitizer,for dystonia

Cerebellar ataxia
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,Scale for the assessment and rating of ataxia (SARA), International Cooperative Ataxia Rating Scale . TIMED UP AND GO TASK (INSTRUMENTAL)
Progressive supranuclear palsy
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.
Corticobasal degeneration
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.
Dementia with Lewy Bodies
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.



Primary Outcome Measures :
  1. MDS-UPDRS part III score [ Time Frame: 3 years ]
    Motor severity


Secondary Outcome Measures :
  1. International Cooperative Ataxia Rating Scale [ Time Frame: 3 years ]
    scale for ataxia

  2. TETRAS [ Time Frame: 3 years ]
    The Essential Tremor Rating Assessment Scale (TETRAS)

  3. MDS-UPDRS total score [ Time Frame: 3 years ]
    General measure for PD

  4. MoCA Montreal - Cognitive Assessment [ Time Frame: 3 years ]
    Cognitive Assessment



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of 300 patients with MDs:

Idiopathic PD , ET, PPS, NPH, dystonia and CAs

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.

Publications:
Responsible Party: Dr. Sharon Hassin, Director, Movement Disorders Institute., Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03269201     History of Changes
Other Study ID Numbers: 4408-17
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Sharon Hassin, Sheba Medical Center:
parkinsonism
ataxia
tremor
dystonia

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Parkinson Disease
Dementia
Atrophy
Ataxia
Dystonia
Dystonic Disorders
Tremor
Movement Disorders
Essential Tremor
Supranuclear Palsy, Progressive
Multiple System Atrophy
Shy-Drager Syndrome
Cerebellar Ataxia
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Pathological Conditions, Anatomical
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Ophthalmoplegia
Ocular Motility Disorders