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

NCT04095377 | Completed

• 1 other identifier: 0292-18
• Study Type: observational
• Target: 875
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (13)

healthy

Other: No intervention, this is a retrospective study.

CVA

Other: No intervention, this is a retrospective study.

Hammorhage

Other: No intervention, this is a retrospective study.

TBI

Other: No intervention, this is a retrospective study.

Concussion

Other: No intervention, this is a retrospective study.

Fibromyalgia

Other: No intervention, this is a retrospective study.

ABD

Other: No intervention, this is a retrospective study.

ADHD

Other: No intervention, this is a retrospective study.

MCI

Other: No intervention, this is a retrospective study.

DEMENTIA

Other: No intervention, this is a retrospective study.

COGNITIVE IMPAIRMENT

Other: No intervention, this is a retrospective study.

COGNITIVE DECLINE

Other: No intervention, this is a retrospective study.

MS

Other: No intervention, this is a retrospective study.

Interventions

No intervention, this is a retrospective study. OTHER

No intervention, this is a retrospective study.

ABD; ADHD; COGNITIVE DECLINE; COGNITIVE IMPAIRMENT; CVA; Concussion; DEMENTIA; Fibromyalgia; Hammorhage; MCI; MS; TBI; healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• QuantalX Neuroscience: lead

Study Sites (1)

Asaf-Harophe

Rishon LeZiyyon, 70300, Israel

Location

MeSH Terms

Conditions

Hemorrhage; Brain Injuries, Traumatic; Brain Concussion; Fibromyalgia; Attention Deficit Disorder with Hyperactivity; Dementia; Neurocognitive Disorders; Cognitive Dysfunction; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Cognition Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: September 19, 2019
• Study Start: March 24, 2019
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: February 16, 2022

Record last verified: 2019-03

Locations

IL (1)