Clinical trial NCT04095377: Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
CVA
Hemorrhage
TBI (Traumatic Brain Injury)
Concussion, Brain
Fibromyalgia
ABD
Adhd
Dementia
Mci
Cognitive Impairment
Cognitive Decline
MS (Multiple Sclerosis)
Lead sponsor: QuantalX Neuroscience
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 875
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Defining Plasticity (the ratio between excitatory to inhibitory brain response) Means and STD in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Connectivity (dispersion of brain signal) Means and STD in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Plasticity (the ratio between excitatory to inhibitory brain response) standard error (SEM) in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Connectivity (dispersion of brain signal) standard error (SEM) in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Plasticity (excitation/inhibition brain response) coefficient of variation (CV%) in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Connectivity (dispersion of brain signal) coefficient of variation (CV%) in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Plasticity (excitation/inhibition brain response) minimum, median, maximum in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Connectivity (dispersion of brain signal) minimum, median, maximum in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Plasticity (excitation/inhibition brain response) 95% confidence interval in each cohort.
timeFrame: through study completion, an average of 1 year
measure: Defining Connectivity (dispersion of brain signal) 95% confidence interval in each cohort.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rishon LeZion
country: Israel
facility: Asaf-Harophe
Study officials:
References: