Brain Network Activation in Patients With Movement Disorders

NCT03269201 | Unknown

• 1 other identifier: 4408-17
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

parkinsonism; ataxia; tremor; dystonia

Outcome Measures

Primary Outcomes (1)

• MDS-UPDRS part III score

  Motor severity

  3 years

Secondary Outcomes (4)

• International Cooperative Ataxia Rating Scale

  3 years

• TETRAS

  3 years

• MDS-UPDRS total score

  3 years

• MoCA Montreal - Cognitive Assessment

  3 years

Study Arms (9)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Movement Disorders Clinic, Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Related Publications (5)

• Reches A, Nir RR, Shram MJ, Dickman D, Laufer I, Shani-Hershkovich R, Stern Y, Weiss M, Yarnitsky D, Geva AB. A novel electroencephalography-based tool for objective assessment of network dynamics activated by nociceptive stimuli. Eur J Pain. 2016 Feb;20(2):250-62. doi: 10.1002/ejp.716. Epub 2015 May 11.

  PMID: 25960035 BACKGROUND

• Reches A, Levy-Cooperman N, Laufer I, Shani-Hershkovitch R, Ziv K, Kerem D, Gal N, Stern Y, Cukierman G, Romach MK, Sellers EM, Geva AB. Brain Network Activation (BNA) reveals scopolamine-induced impairment of visual working memory. J Mol Neurosci. 2014 Sep;54(1):59-70. doi: 10.1007/s12031-014-0250-6. Epub 2014 Feb 18.

  PMID: 24535560 BACKGROUND

• Reches A, Laufer I, Ziv K, Cukierman G, McEvoy K, Ettinger M, Knight RT, Gazzaley A, Geva AB. Network dynamics predict improvement in working memory performance following donepezil administration in healthy young adults. Neuroimage. 2014 Mar;88:228-41. doi: 10.1016/j.neuroimage.2013.11.020. Epub 2013 Nov 21.

  PMID: 24269569 BACKGROUND

• Sang L, Zhang J, Wang L, Zhang J, Zhang Y, Li P, Wang J, Qiu M. Alteration of Brain Functional Networks in Early-Stage Parkinson's Disease: A Resting-State fMRI Study. PLoS One. 2015 Oct 30;10(10):e0141815. doi: 10.1371/journal.pone.0141815. eCollection 2015.

  PMID: 26517128 BACKGROUND

• Gao LL, Wu T. The study of brain functional connectivity in Parkinson's disease. Transl Neurodegener. 2016 Oct 28;5:18. doi: 10.1186/s40035-016-0066-0. eCollection 2016.

  PMID: 27800157 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia; Hydrocephalus, Normal Pressure; Cerebellar Ataxia; Multiple System Atrophy; Supranuclear Palsy, Progressive; Corticobasal Degeneration; Lewy Body Disease; Parkinsonian Disorders; Ataxia; Tremor

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hydrocephalus; Cerebellar Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Eye Diseases; Dementia; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Movement Disorders Institute.

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 31, 2017
• Study Start: March 1, 2019
• Primary Completion: December 15, 2021
• Study Completion: September 15, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

IL (1)