HealthyNCT04095377
Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.
An observational study of Healthy and CVA, run by QuantalX Neuroscience at 1 site in Israel.
Trial summary
DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, CVA, Hemorrhage
- How many people
- 875 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Mar 2019to 14 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects with no EEG test or that their EEG recording is in pure quality, not allowing analysis of the data.
Trial locations and contacts
1 site in 1 country.
About this study
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
DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data.
Read the 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.
- Conditions
- Healthy, CVA, Hemorrhage, TBI (Traumatic Brain Injury), Concussion, Brain, Fibromyalgia
- Being tested
- No intervention, this is a retrospective study.
- Medical subject headings
- Hemorrhage, Brain Injuries, Traumatic, Brain Concussion, Fibromyalgia, Attention Deficit Disorder with Hyperactivity, Dementia, Neurocognitive Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, this is a retrospective study.Other
No intervention, this is a retrospective study.
| Study group | Role | What they receive |
|---|---|---|
| healthy | Not described Receives: Other: No intervention, this is a retrospective study. | |
| CVA | Not described Receives: Other: No intervention, this is a retrospective study. | |
| Hammorhage | Not described Receives: Other: No intervention, this is a retrospective study. | |
| TBI | Not described Receives: Other: No intervention, this is a retrospective study. | |
| Concussion | Not described Receives: Other: No intervention, this is a retrospective study. | |
| Fibromyalgia | Not described Receives: Other: No intervention, this is a retrospective study. | |
| ABD | Not described Receives: Other: No intervention, this is a retrospective study. | |
| ADHD | Not described Receives: Other: No intervention, this is a retrospective study. | |
| MCI | Not described Receives: Other: No intervention, this is a retrospective study. | |
| DEMENTIA | Not described Receives: Other: No intervention, this is a retrospective study. | |
| COGNITIVE IMPAIRMENT | Not described Receives: Other: No intervention, this is a retrospective study. | |
| COGNITIVE DECLINE | Not described Receives: Other: No intervention, this is a retrospective study. | |
| MS | Not described Receives: Other: No intervention, this is a retrospective study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start24 Mar 2019
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 875 participants (actual)
Sponsor and investigators
- Lead sponsor
- QuantalX Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095377
- Sponsor's protocol ID
- 0292-18
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04095377
- Acronym / sponsor ID
- 0292-18
- Conditions
- Healthy, CVA, Hemorrhage, TBI (Traumatic Brain Injury), Concussion, Brain, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 875 participants (actual)
- Lead sponsor
- QuantalX NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2019 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects with no EEG test or that their EEG recording is in pure quality, not allowing analysis of the data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, this is a retrospective study.No intervention, this is a retrospective study. | Other | ABD, ADHD, COGNITIVE DECLINE, COGNITIVE IMPAIRMENT, CVA, Concussion, DEMENTIA, Fibromyalgia, Hammorhage, MCI, MS, TBI, healthy |
Primary outcome
Defining Plasticity (the ratio between excitatory to inhibitory brain response) Means and STD in each cohort.
Time frame: 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.
Time frame: through study completion, an average of 1 year
Measure of the mean and STD Connectivity of each cohort.
Defining Plasticity (the ratio between excitatory to inhibitory brain response) standard error (SEM) in each cohort.
Time frame: 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) standard error (SEM) in each cohort.
Time frame: 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.
Time frame: 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) coefficient of variation (CV%) in each cohort.
Time frame: through study completion, an average of 1 year
Measure of the coefficient of variation (CV%) of Connectivity of each cohort.
Defining Plasticity (excitation/inhibition brain response) minimum, median, maximum in each cohort.
Time frame: through study completion, an average of 1 year
Measure of the minimum, median, maximum of Plasticity of each cohort.
Defining Connectivity (dispersion of brain signal) minimum, median, maximum in each cohort.
Time frame: 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.
Time frame: through study completion, an average of 1 year
Measure of the 95% confidence interval of Plasticity of each cohort.
Defining Connectivity (dispersion of brain signal) 95% confidence interval in each cohort.
Time frame: through study completion, an average of 1 year
Measure of the 95% confidence interval of Connectivity of each cohort.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and CVA, run by QuantalX Neuroscience at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defining Plasticity (the ratio between excitatory to inhibitory brain response) Means and STD in each cohort. (time frame: through study completion, an average of 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.