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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Hemorrhage; Cognitive Impairment; Dementia; Fibromyalgia; TBI (Traumatic Brain Injury); Cognitive Decline; Concussion, Brain; MS (Multiple Sclerosis); Adhd; CVA; ABD; Mci
• Intervention / Treatment: Other: No intervention, this is a retrospective study.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 875

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: Non-Probability Sample

Study Population

Patient arriving to be treated at the Sagol center for hyperbaric medicine and research at Asaf-Harophe in te years of 2017-2019.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

13

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
ADHD	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
Fibromyalgia	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
CVA	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
Hammorhage	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
TBI	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
Concussion	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
ABD	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
MCI	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
DEMENTIA	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
COGNITIVE IMPAIRMENT	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
COGNITIVE DECLINE	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.
MS	Other: No intervention, this is a retrospective study.; No intervention, this is a retrospective study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defining Plasticity (the ratio between excitatory to inhibitory brain response) Means and STD in each cohort.	Measure of the mean and STD Plasticity of each cohort.	through study completion, an average of 1 year
Defining Connectivity (dispersion of brain signal) Means and STD in each cohort.	Measure of the mean and STD Connectivity of each cohort.	through study completion, an average of 1 year
Defining Plasticity (the ratio between excitatory to inhibitory brain response) standard error (SEM) in each cohort.	Measure of the standard error (SEM) of Plasticity of each cohort.	through study completion, an average of 1 year
Defining Connectivity (dispersion of brain signal) standard error (SEM) in each cohort.	Measure of the standard error (SEM) of Connectivity of each cohort.	through study completion, an average of 1 year
Defining Plasticity (excitation/inhibition brain response) coefficient of variation (CV%) in each cohort.	Measure of the coefficient of variation (CV%) of Plasticity of each cohort.	through study completion, an average of 1 year
Defining Connectivity (dispersion of brain signal) coefficient of variation (CV%) in each cohort.	Measure of the coefficient of variation (CV%) of Connectivity of each cohort.	through study completion, an average of 1 year
Defining Plasticity (excitation/inhibition brain response) minimum, median, maximum in each cohort.	Measure of the minimum, median, maximum of Plasticity of each cohort.	through study completion, an average of 1 year
Defining Connectivity (dispersion of brain signal) minimum, median, maximum in each cohort.	Measure of the minimum, median, maximum of Connectivity of each cohort.	through study completion, an average of 1 year
Defining Plasticity (excitation/inhibition brain response) 95% confidence interval in each cohort.	Measure of the 95% confidence interval of Plasticity of each cohort.	through study completion, an average of 1 year
Defining Connectivity (dispersion of brain signal) 95% confidence interval in each cohort.	Measure of the 95% confidence interval of Connectivity of each cohort.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: QuantalX Neuroscience

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2019
• Primary Completion (ACTUAL): February 14, 2022
• Study Completion (ACTUAL): February 14, 2022

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Wounds and Injuries; Neurocognitive Disorders; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Multiple Sclerosis; Brain Injuries; Hemorrhage; Fibromyalgia; Brain Injuries, Traumatic; Cognitive Dysfunction; Brain Concussion
• Other Study ID Numbers: 0292-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No