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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095377
• Other study ID #: 0292-18
• Status: Completed
• Start date: March 24, 2019
• Est. completion date: February 14, 2022

Study information

• Verified date: March 2019
• Source: QuantalX Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 875
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ABD
• Adhd
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Concussion, Brain
• CVA
• Dementia
• Fibromyalgia
• Healthy
• Hemorrhage
• Mci
• MS (Multiple Sclerosis)
• Multiple Sclerosis
• TBI (Traumatic Brain Injury)

Intervention

Other:
• No intervention, this is a retrospective study.
No intervention, this is a retrospective study.

Locations

Country	Name	City	State
Israel	Asaf-Harophe	Rishon LeZion

Sponsors (1)

Lead Sponsor	Collaborator
QuantalX Neuroscience

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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