Equipment and SuppliesNCT05722639
Evaluation of Accuracy and Consistency of the X-Trodes System
An observational study of Equipment and Supplies, run by B-Cube at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the accuracy and consistency of the X-Trodes acquisition system compared to a Food and Drug Administration (FDA)-cleared clinical electrophysiology device. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Equipment and Supplies
- What is being tested?
- X-Trodes acquisition system
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 4 Jan 2024
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals ages 21 and over who are able to come to the study site and sit for about 30 minutes while two electrophysiology devices are capturing EEG, EOG, EMG, ECG signals from their body. Subjects should have no beard (to ease the signal capturing), not be pregnant, not suffer from sleep apnea, and comfortable with the study protocol (i.e., sign a consent form).
Who may be able to join
- To be included in the study, subjects must meet all the following inclusion criteria:
- Adults (age 21 - 99)
- Referred to an electrophysiology test by either neurologist or cardiologist in the last 5 years
- Produce interpretable electrophysiological signals by the acquisition devices
Who cannot join
- Did not sign the informed consent
- Cannot maintain the electrodes attached to their skin (i.e., due to beard on the chin area)
- Diagnosed as suffering from sleep apnea
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the accuracy and consistency of the X-Trodes acquisition system compared to a Food and Drug Administration (FDA)-cleared clinical electrophysiology device.
Read the detailed description
The study aims to demonstrate that the performance of the study X-Trodes acquisition system is equivalent to that of an FDA-cleared clinical electrophysiology devices (in measuring electroencephalography , electrooculography, electromyography, and electrocardiogram signals).
Subjects will wear both devices simultaneously while signals are captured in resting state. Following, an evaluation of the similarity of signals between the two devices will be conducted. The evaluation will determine if the quality of the X-Trodes system matches that of the FDA-approved device.
- Conditions
- Equipment and Supplies
- Being tested
- X-Trodes acquisition system
- Keywords
- Electrophysiology, Electrooculography, Electromyography, Electrocardiogram, Device, Acquisition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-Trodes acquisition systemDevice
No intervention. The participants will sit passively while electrophysiology signals are captured from two devices in order to evaluate the signal quality.
| Study group | Role | What they receive |
|---|---|---|
| Representative sample of the U.S. population | Subjects will be fitted with two electrophysiology acquisition systems (one is FDA-approved, and the other is the one evaluated).
Signals from both systems will be acquired simultaneously while the subjects rest and perform no cognitive tasks.
Following, the signals from both devices will be assessed by an electrophysiology expert to determine if they are of equal quality. Receives: Device: X-Trodes acquisition system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signals alignment between two devices
Electrophysiological time-series (EEG, EOG, ECG, EMG) in 2 recorded devices will be compared.
For each subject, the time-series from 2 devices will be assessed by three independent raters (US board-certified neurologist/cardiologist). The raters will rank the quality of signals (1-signal is corrupt or unusable; 5-signal is clean and useable). Raters will be blind to the signal device.
Time-series will be deemed interpretable if at least 2 of the raters scored it 4-5.
Following the rater evaluation, the outcome will also be reported as a binary output where scores of 4-5 are considered interpretable signals.
The trial will be considered successful if the number of high-quality (mean score 4-5) X-Trode series will be within one-standard deviation from the FDA-approved device's series while both systems yield over 80% high-quality signals.
Measured: Within 3 months from the completion of data collection.
Assessment of agreement among raters
Agreement among raters will be evaluated by calculating the Intraclass correlation coefficient (ICC). ICC will be calculated for each of the 4 electrophysiological modalities. The acceptance criterion for ICC is 0.60 and higher.
If no agreement among rates is observed (ICC < 0.6) then Spearman correlation coefficient between each pair of raters for the specific signal (per subect, per time-series) will be calculated and the rankings of the two raters with the highest correlation coefficient will be selected for the analysis.
Measured: Within 3 months from the completion of data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start23 Jan 2023
- Primary completion31 Mar 2023
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equipment and SuppliesStudies 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
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- B-Cube
- Sponsor type
- University, hospital or other
- Collaborators
- X-Trodes
- Responsible party
- Principal investigator, Moran Cerf, B-Cube
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722639
- Sponsor's protocol ID
- Pro00068380
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy and Consistency of the X-Trodes System
- ClinicalTrials.gov ID
- NCT05722639
- Acronym / sponsor ID
- Pro00068380
- Conditions
- Equipment and Supplies
- Keywords
- Electrophysiology, Electrooculography, Electromyography, Electrocardiogram, Device, Acquisition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- B-CubeUniversity, hospital or other
- Collaborators
- X-Trodes
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 10 Feb 2023 (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.
The purpose of this study is to evaluate the accuracy and consistency of the X-Trodes acquisition system compared to a Food and Drug Administration (FDA)-cleared clinical electrophysiology device.
Detailed description
The study aims to demonstrate that the performance of the study X-Trodes acquisition system is equivalent to that of an FDA-cleared clinical electrophysiology devices (in measuring electroencephalography , electrooculography, electromyography, and electrocardiogram signals).
Subjects will wear both devices simultaneously while signals are captured in resting state. Following, an evaluation of the similarity of signals between the two devices will be conducted. The evaluation will determine if the quality of the X-Trodes system matches that of the FDA-approved device.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Representative sample of the U.S. population | – | Device: X-Trodes acquisition systemSubjects will be fitted with two electrophysiology acquisition systems (one is FDA-approved, and the other is the one evaluated). Signals from both systems will be acquired simultaneously while the subjects rest and perform no cognitive tasks. Following, the signals from both devices will be assessed by an electrophysiology expert to determine if they are of equal quality. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals ages 21 and over who are able to come to the study site and sit for about 30 minutes while two electrophysiology devices are capturing EEG, EOG, EMG, ECG signals from their body. Subjects should have no beard (to ease the signal capturing), not be pregnant, not suffer from sleep apnea, and comfortable with the study protocol (i.e., sign a consent form).
Key inclusion criteria (4 listed)
- Adults (age 21 - 99)
- Referred to an electrophysiology test by either neurologist or cardiologist in the last 5 years
- Produce interpretable electrophysiological signals by the acquisition devices
Key exclusion criteria (4 listed)
- Did not sign the informed consent
- Cannot maintain the electrodes attached to their skin (i.e., due to beard on the chin area)
- Diagnosed as suffering from sleep apnea
- Pregnant or lactating women
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 |
|---|---|---|
| X-Trodes acquisition systemNo intervention. The participants will sit passively while electrophysiology signals are captured from two devices in order to evaluate the signal quality. | Device | Representative sample of the U.S. population |
Primary outcome
Signals alignment between two devices
Time frame: Within 3 months from the completion of data collection.
Electrophysiological time-series (EEG, EOG, ECG, EMG) in 2 recorded devices will be compared. For each subject, the time-series from 2 devices will be assessed by three independent raters (US board-certified neurologist/cardiologist). The raters will rank the quality of signals (1-signal is corrupt or unusable; 5-signal is clean and useable). Raters will be blind to the signal device. Time-series will be deemed interpretable if at least 2 of the raters scored it 4-5. Following the rater evaluation, the outcome will also be reported as a binary output where scores of 4-5 are considered interpretable signals. The trial will be considered successful if the number of high-quality (mean score 4-5) X-Trode series will be within one-standard deviation from the FDA-approved device's series while both systems yield over 80% high-quality signals.
Assessment of agreement among raters
Time frame: Within 3 months from the completion of data collection.
Agreement among raters will be evaluated by calculating the Intraclass correlation coefficient (ICC). ICC will be calculated for each of the 4 electrophysiological modalities. The acceptance criterion for ICC is 0.60 and higher. If no agreement among rates is observed (ICC < 0.6) then Spearman correlation coefficient between each pair of raters for the specific signal (per subect, per time-series) will be calculated and the rankings of the two raters with the highest correlation coefficient will be selected for the analysis.
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 1 Mar 2024.
- Individual participant dataSharing planned: No
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Equipment and Supplies
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 Equipment and Supplies, run by B-Cube at 1 site in United States.
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 4 inclusion and 4 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 1 Mar 2024. 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 United States. 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?
Signals alignment between two devices (time frame: Within 3 months from the completion of data collection.). The study lists 2 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 1 Mar 2024.