Parkinson DiseaseBNA-MDiNCT03269201
Brain Network Activation in Patients With Movement Disorders
An observational study of Parkinson Disease and Essential Tremor, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease, Essential Tremor, Dystonia
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 300 patients with MDs: Idiopathic PD , ET, PPS, NPH, dystonia and CAs
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia, Normal Pressure Hydrocephalus, Cerebellar Ataxia, Multiple System Atrophy
- Keywords
- parkinsonism, ataxia, tremor, dystonia
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia, Hydrocephalus, Normal Pressure, Cerebellar Ataxia, Multiple System Atrophy, Supranuclear Palsy, Progressive, Corticobasal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS part III score
Motor severity
Measured: 3 years
Secondary outcomes (4)
International Cooperative Ataxia Rating Scale
scale for ataxia
Measured: 3 years
TETRAS
The Essential Tremor Rating Assessment Scale (TETRAS)
Measured: 3 years
MDS-UPDRS total score
General measure for PD
Measured: 3 years
MoCA Montreal - Cognitive Assessment
Cognitive Assessment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Mar 2019
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Sharon Hassin, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269201
- Sponsor's protocol ID
- 4408-17
- Acronym
- BNA-MDi
- Status last verified
- Mar 2021
- First submitted
- 22 Aug 2017
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25960035Reches 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.
PubMed 24535560Reches 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.
PubMed 24269569Sang 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.
PubMed 26517128Gao 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.
PubMed 27800157
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03269201
- Acronym / sponsor ID
- BNA-MDi / 4408-17
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia, Normal Pressure Hydrocephalus, Cerebellar Ataxia, Multiple System Atrophy
- Keywords
- parkinsonism, ataxia, tremor, dystonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 300 patients with MDs: Idiopathic PD , ET, PPS, NPH, dystonia and CAs
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MDS-UPDRS part III score
Time frame: 3 years
Motor severity
4 secondary outcomes
International Cooperative Ataxia Rating Scale
Time frame: 3 years
TETRAS
Time frame: 3 years
MDS-UPDRS total score
Time frame: 3 years
MoCA Montreal - Cognitive Assessment
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Background: PubMed 25960035Reches 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.
- Background: PubMed 24535560Reches 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.
- Background: PubMed 24269569Reches 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.
- Background: PubMed 26517128Sang 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.
- Background: PubMed 27800157Gao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Essential Tremor, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS part III score (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269201, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.