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

NCT03832413 | Completed FDA Device

• 1 other identifier: QuantalX_pilot_asaf_harophe
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; TBI; Fibromyalgia; PDD; Adhd; ABD; Ptsd; Healthy; MCI; Dementia; Cognitive Impairment; Cognitive Decline

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cluster TMS Evoked Responses' (TEPs') features such as amplitude, latency, Area under the curve and slopes.

  through study completion, an average of 1 year

Study Arms (10)

Stroke

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

TBI

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

ABD

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

Fibromyalgia

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

PDD

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

ADHD

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

MCI

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

Dementia

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

Healthy

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

Cognitive impairment

Diagnostic Test: DELPhI (TMS-EEG analysis)

Diagnostic Test: DELPhI (TMS-EEG analysis)

Interventions

DELPhI (TMS-EEG analysis) DIAGNOSTIC_TEST

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; ADHD; Cognitive impairment; Dementia; Fibromyalgia; Healthy; MCI; PDD; Stroke; TBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• QuantalX Neuroscience: lead

Study Sites (1)

Asaf-Harophe

Rishon LeZiyyon, 70300, Israel

Location

MeSH Terms

Conditions

Stroke; Fibromyalgia; Attention Deficit Disorder with Hyperactivity; Stress Disorders, Post-Traumatic; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Neurocognitive Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: February 6, 2019
• Study Start: April 23, 2018
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: February 16, 2022

Record last verified: 2019-02

Locations

IL (1)