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

Characterization of the DELPhI System in Assessing Brain's Functionality in Different Neurological Disorders-A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Healthy; Cognitive Impairment; Dementia; Fibromyalgia; Cognitive Decline; MCI; TBI; Adhd; PDD; Ptsd; ABD
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 193

Contacts and Locations

Study Locations

• Israel
  • Rishon LeZion, Israel, 70300
    • Asaf-Harophe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: QuantalX Neuroscience

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2018
• Primary Completion (ACTUAL): February 14, 2022
• Study Completion (ACTUAL): February 14, 2022

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (ACTUAL): February 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Cognition Disorders; Fibromyalgia; Nervous System Diseases; Cognitive Dysfunction
• Other Study ID Numbers: QuantalX_pilot_asaf_harophe

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No