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Completed

NCT Number: NCT04095377

Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.

DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data.

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Key information

Conditions

Healthy ABD ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic CVA Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Cognitive Impairment Concussion, Brain Craniocerebral Trauma Dementia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fibromyalgia Head Injuries, Closed Hemorrhage Immune System Diseases MCI MS (Multiple Sclerosis) Mental Disorders Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Neurodevelopmental Disorders Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases TBI (Traumatic Brain Injury) Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asaf-Harophe

Rishon LeZiyyon, 70300, Israel

About this study

Collection of EEG data, recorded at Sagol center for hyperbaric medicine and research in the years of 2017-2019 of patients arriving to be treated at the hyperbaric chamber before,during and after treatments. EEG was recorded of patients during cognitive tests, resting state and during magnetic stimulation as a part of other array of tests performed at the Sagol center. Anonymous EEG data along with MRI scans, PET-CT, SPECT, cognitive tests, Medical history and medications will be transferred to QuantalX Neuroscience LTD.

QuantalX Neuroscience is intending to use the above mentioned data in order to improve DELPhI, an algorithm for the analysis of EEG recordings in response to magnetic stimulation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects over the age of 18.
  • Subjects that performed at least one EEG test as a part of their hyperbaric treatment at Sagol center Asaf-Harophe.

Exclusion criteria

  • Subjects with no EEG test or that their EEG recording is in pure quality, not allowing analysis of the data.

Treatment and study plan

No intervention, this is a retrospective study.

Other

No intervention, this is a retrospective study.

Primary outcomes

  1. Defining Plasticity (the ratio between excitatory to inhibitory brain response) Means and STD in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the mean and STD Plasticity of each cohort.

  2. Defining Connectivity (dispersion of brain signal) Means and STD in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the mean and STD Connectivity of each cohort.

  3. Defining Plasticity (the ratio between excitatory to inhibitory brain response) standard error (SEM) in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the standard error (SEM) of Plasticity of each cohort.

  4. Defining Connectivity (dispersion of brain signal) standard error (SEM) in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the standard error (SEM) of Connectivity of each cohort.

  5. Defining Plasticity (excitation/inhibition brain response) coefficient of variation (CV%) in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the coefficient of variation (CV%) of Plasticity of each cohort.

  6. Defining Connectivity (dispersion of brain signal) coefficient of variation (CV%) in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the coefficient of variation (CV%) of Connectivity of each cohort.

  7. Defining Plasticity (excitation/inhibition brain response) minimum, median, maximum in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the minimum, median, maximum of Plasticity of each cohort.

  8. Defining Connectivity (dispersion of brain signal) minimum, median, maximum in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the minimum, median, maximum of Connectivity of each cohort.

  9. Defining Plasticity (excitation/inhibition brain response) 95% confidence interval in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the 95% confidence interval of Plasticity of each cohort.

  10. Defining Connectivity (dispersion of brain signal) 95% confidence interval in each cohort.

    Time frame: through study completion, an average of 1 year

    Measure of the 95% confidence interval of Connectivity of each cohort.

Sponsors and collaborators

Lead sponsor

QuantalX Neuroscience

Industry

Registry information

Official study title

Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019 - A Retrospective Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2019
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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