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Characterization of the DELPhI System in Assessing Brain's Functionality in Different Neurological Disorders

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ClinicalTrials.gov Identifier: NCT03832413
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
QuantalX Neuroscience

Brief Summary:
We use Transcranial magnetic stimulation (TMS), combined with simultaneous registration of electroencephalograph (EEG),for examining human cortical functionality. TMS-EEG is a noninvasive brain stimulation method that allows to study human cortical function in vivo. EEG provides an opportunity to directly measure the cerebral response to TMS, measuring the cortical TMS Evoked potential (TEP). In this study we measure TEPs, in a wide variety of neurological conditions and healthy as a measure of cerebral reactivity across wide areas of neocortex.

Condition or disease Intervention/treatment
Stroke TBI Fibromyalgia PDD Adhd ABD Ptsd Healthy MCI Dementia Cognitive Impairment Cognitive Decline Diagnostic Test: DELPhI (TMS-EEG analysis)

Detailed Description:

Brain network plasticity evaluation has been shown extensively essential for understanding and monitoring of brain functional changes and brain disorders. However, existing clinically used imaging methods are unable to robustly indicate plasticity or plasticity changes. Therefore, there is a great need for developing such an imaging tool for brain functional evaluation. In basic neuroscience research plasticity evaluation is performed by conducting electrophysiological measurements in vivo. By using EEG - combined with TMS stimulation this methodology can be transformed into clinically used plasticity and connectivity assessment for evaluation of functional brain status. This study may thus introduce a novel, non-invasive and efficient method for brain functional imaging. DELPhI evaluation will offer a true multimodality imaging by combining EEG and TMS that allows a quantative objective and direct identification of disease assessment. There is a real unmet need for an accurate and objective evaluation that together with the common clinical practice will provide neurologists and psychiatrists a more definite and personalized treatment prescription.

Studies integrating TMS with EEG (TMS-EEG) have shown that TMS produces waves of activity that reverberate throughout the cortex and that are reproducible and reliable thus providing direct information about cortical excitability and connectivity with excellent time resolution. By evaluating the propagation of evoked activity in different behavioral states and in different tasks, TMS-EEG has been used to causally probe the dynamic effective connectivity of human brain networks. When applying the TMS coil above the motor cortex, a cascade effect called the motor-evoked potential (MEP), is initiated. The MEP is measurable at peripheral muscles. The Motor cortex is a brain structure located between the frontal and parietal cortices. Pyramidal neurons in the motor cortex, upper motor neuron going through the brain stem, send signals to lower motor neuron in the spinal cord which stimulate muscle fibers. TMS stimulus to the Motor cortex evokes a brain response which propagates to different brain regions in addition to the peripheral limb muscles [20]. An important feature of TEP topography is that even though only one cortical hemisphere is stimulated, bihemispheric EEG evoked responses are evoked with different features. TMS-evoked activity propagates from the stimulation site ipsilaterally via association fibers and contralaterally via transcallosal fibers and to subcortical structures via projection fibers. These TMS-evoked cortical potentials (TEPs) last for up to 300 ms in both the vicinity of the stimulation as well as in remote interconnected brain areas reflect long term changes in cortical network excitation-inhibition balance refeed to as brain network plasticity. A single TMS pulse delivered over the primary motor cortex (M1) results in a sequence of positive and negative EEG peaks at specific latencies (i.e., P25, N45, P70, N100, and P180).

In this study a wide population of subjects will be recruited. this population will include different neurological conditions and healthy subjects, arriving to the Hyperbaric center at Asaf-Harophe hospital. Each subject will be tested once before treatment initiation and subsequent tests will be performed also after treatment termination or at follow up time points. Each evaluation will last up to 90 minutes and will include affixed stimulation protocol ranging Up to 1000 TMS pulses, with intensities between 60-130% of motor threshold (MT). Inter-stimuli frequency will change from 0.01 up to 20 Hz.Existing clinical data such as MRI scans, neurocognitive assessments and clinical evaluations will be collected out of patient files. EEG data recorded will be analyzed and corrolations to the clinical data will be tested.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of the DELPhI System in Assessing Brain's Functionality in Different Neurological Disorders-A Pilot Study
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stroke
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

TBI
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

ABD
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

Fibromyalgia
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

PDD
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

ADHD
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

MCI
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

Dementia
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

Healthy
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).

Cognitive impairment
Diagnostic Test: DELPhI (TMS-EEG analysis)
Diagnostic Test: DELPhI (TMS-EEG analysis)
We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).




Primary Outcome Measures :
  1. Correlation between DELPhI's parameters to MRI scans [ Time Frame: through study completion, an average of 1 year ]
    Correlation between DELPhI parameters to cognitive assessment by MRI/CT and computerized cognitive evaluation (Mindstreems cognitive battery test).

  2. Correlation between DELPhI's parameters to cognitive assessment [ Time Frame: through study completion, an average of 1 year ]
    Correlation between DELPhI parameters to MRI/CT and computerized cognitive evaluation (Mindstreems cognitive battery test).


Secondary Outcome Measures :
  1. Cluster TMS Evoked Responses' (TEPs') features such as amplitude, latency, Area under the curve and slopes. [ Time Frame: through study completion, an average of 1 year ]
    Calculating potential clusters based on TEP's features at different stimulation conditions. Features such as amplitude, area under the curve, slope and latency.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients arriving to the Sagol center for Hyperbaric medicine at Assaf harofe Medical center, undergoing a series of hyperbaric treatment sessions and will be found compatible to inclusion/exclusion criteria.
Criteria

Inclusion Criteria:

  1. Man and woman at the ages of ≥18 years.
  2. Designated to perform a neurocognitive evaluation at the Sagol center for hyperbaric medicine and research, at Assaf-Harofe Medical center.

Exclusion Criteria:

  1. Under 18 years of age.
  2. With a skin condition on the scalp preventing the placement of EEG cap.
  3. Pregnant or breastfeeding woman.
  4. Unable to give an informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832413


Contacts
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Contact: Iftach Dolev, PhD +972-44659491 doleviftach@gmail.com
Contact: Noa Zifman, MSc +972-37553213 noazif@gmail.com

Locations
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Israel
Asaf-Harophe Recruiting
Rishon LeZion, Israel, 70300
Contact: Shai Efrati, MD    +972-89779393    efratishai@013.net   
Sponsors and Collaborators
QuantalX Neuroscience

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Responsible Party: QuantalX Neuroscience
ClinicalTrials.gov Identifier: NCT03832413     History of Changes
Other Study ID Numbers: QuantalX_pilot_asaf_harophe
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Fibromyalgia
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases