Brain Network Activation in Patients With Movement Disorders

Related Clinical Trial
Optimization of Morphomer-based Alpha-synuclein PET Tracers Evaluation of [18F]APN-1607 as a PET Biomarker A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP) RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY Complex Eye Movements in Parkinson’s Disease and Related Movement Disorders tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study Application od Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA) Remote Monitoring in Progressive Supranuclear Palsy (PSP) Trial of Parkinson’s And Zoledronic Acid Rho Kinase (ROCK) Inhibitor in Tauopathies – 1 UPenn Observational Research Repository on Neurodegenerative Disease Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies The MOTIVE-PSP Initiative A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP) Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of NIO752 in Progressive Supranuclear Palsy Misfolded Proteins in the Skin of People With Parkinson’s Disease and Other Parkinsonism Neurodegenerative Diseases Registry Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy 18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer’s Disease, Other Dementias and Normal Controls Brain Network Activation in Patients With Movement Disorders Neurologic Stem Cell Treatment Study ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes ADDIA Proof-of-Performance Clinical Study Defining Phenotypes of Movement Disorders :Parkinson’s Plus Disorders (PD), Essential Tremor (ET), Cortical Basal Degeneration (CBD), Multiple Systems Atrophy (MSA), Magnetoencephalography. Gait Analysis in Neurological Disease Diagnosing Frontotemporal Lobar Degeneration Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies Study of the Neural Basis of Analogical Reasoning Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Phase 1 Test-retest Evaluation of [18F]MNI-958 PET Diagnostic and Prognostic Biomarkers in Parkinson Disease Tau Imaging With JNJ067 Research of Biomarkers in Parkinson Disease More Than a Movement Disorder: Applying Palliative Care to Parkinson’s Disease Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism Identifying Biomarkers of Parkinson’s Disease Using Magnetic Resonance Imaging (MRI) Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL) Davunetide (AL-108) in Predicted Tauopathies – Pilot Study Robot Walking Rehabilitation in Parkinson’s Disease Human CNS Tau Kinetics in Tauopathies 4-Repeat Tauopathy Neuroimaging Initiative – Cycle 2 In-Home Care for Patients With PSP and Related Disorders Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA) Biomarkers in Parkinsonian Syndromes Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain Effects of Coenzyme Q10 in PSP and CBD 2-(1-{6-[(2-[F-18]Fluoroethyl) (Methyl)Amino]-2-naphthyl} Ethylidene) Malononitrile-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism Oxford Study of Quantification in Parkinsonism A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects The Neural Basis for Frontotemporal Degeneration Analysis of the Enteric Nervous System Using Colonic Biopsies Evaluation of Tolfenamic Acid in Individuals With PSP at 12-Weeks Chromatic Pupillometry to Assess the Melanopsin-Light Pathway in Progressive Supranuclear Palsy 4 Repeat Tauopathy Neuroimaging Initiative A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson’s Disease and Progressive Supranuclear Palsy. Safety Study of TPI-287 to Treat CBS and PSP Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain Neuroprotection and Natural History in Parkinson’s Plus Syndromes (NNIPPS) Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy. Clinical Trial to Evaluate Bone Marrow Stem Cell Therapy for PSP, a Rare Form of Parkinsonism tDCS Plus Physical Therapy for Progressive Supranuclear Palsy Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration Risk Factors for Progressive Supranuclear Palsy (PSP) Continuously Infused Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (GDNF) to Treat Progressive Supranuclear Palsy Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy Neuropsychological Evaluation for Early Diagnosis of PSP Evaluating Cerebrospinal Fluid Biomarkers in Alzheimer’s, Progressive Supranuclear Palsy Subjects, and Controls A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104 Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003 PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy Young Plasma Transfusions for Progressive Supranuclear Palsy Study of BIIB092 in Participants With Progressive Supranuclear Palsy A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP) Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy Deep TMS for the Treatment of Patients With Parkinson’s Disease and Progressive Supranuclear Palsy Rehabilitation in Patients With Progressive Supranuclear Palsy A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP) Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP). Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine) Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112 Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy Efficacy, Tolerability and Safety of Azilect in Subjects With Progressive Supranuclear Palsy Postural Instability in Progressive Supranuclear Palsy

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

, , 

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

, , 


Verification Date

March 2021