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

Completed

• Conditions: Healthy; Concussion, Brain; Adhd; Hemorrhage; Fibromyalgia; ABD; Mci; Cognitive Decline; MS (Multiple Sclerosis); TBI (Traumatic Brain Injury)
• Interventions: Other: No intervention, this is a retrospective study.

• Registration Number: NCT04095377
• Lead Sponsor: QuantalX Neuroscience

Brief Summary

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

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 Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-24
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Primary Completion: 2022-02-14
• Study Completion: 2022-02-14
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 875

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hammorhage	No intervention, this is a retrospective study.	-
MS	No intervention, this is a retrospective study.	-
healthy	No intervention, this is a retrospective study.	-
CVA	No intervention, this is a retrospective study.	-
TBI	No intervention, this is a retrospective study.	-
MCI	No intervention, this is a retrospective study.	-
DEMENTIA	No intervention, this is a retrospective study.	-
COGNITIVE IMPAIRMENT	No intervention, this is a retrospective study.	-
ABD	No intervention, this is a retrospective study.	-
Concussion	No intervention, this is a retrospective study.	-
Fibromyalgia	No intervention, this is a retrospective study.	-
ADHD	No intervention, this is a retrospective study.	-
COGNITIVE DECLINE	No intervention, this is a retrospective study.	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Asaf-Harophe; 🇮🇱 Rishon LeZion, Israel