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

Sponsor
QuantalX Neuroscience (Industry)
Overall Status
Completed
CT.gov ID
NCT04095377
Collaborator
(none)
875
1
34.8
25.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
875 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Mar 24, 2019
Actual Primary Completion Date :
Feb 14, 2022
Actual Study Completion Date :
Feb 14, 2022

Arms and Interventions

Arm Intervention/Treatment
healthy

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.

Fibromyalgia

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.

ADHD

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asaf-Harophe Rishon LeZion Israel 70300

Sponsors and Collaborators

  • QuantalX Neuroscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
QuantalX Neuroscience
ClinicalTrials.gov Identifier:
NCT04095377
Other Study ID Numbers:
  • 0292-18
First Posted:
Sep 19, 2019
Last Update Posted:
Feb 16, 2022
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022