Stroke, AcuteEPISODE_VSNCT05602740
Detection of hEad Pulse for Ischemic StrOke Verification Study
An observational study of Stroke, Acute, run by MindRhythm, Inc. at 1 site in United States.
Trial summary
Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Harmony
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 1 Oct 2023
- 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
- Adult, Older adult
Study population: Patients who are being evaluated in the prehospital environment by Paramedics/EMTs in whom stroke is suspected.
Who may be able to join
- suspected stroke in the prehospital setting
Who cannot join
- scalp laceration
- Patient refusal
- Prisoner, other vulnerable population
- Prehospital provider feels that the recording may interfere with care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study
Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.
Read the detailed description
Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.
- Conditions
- Stroke, Acute
- Being tested
- Harmony
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HarmonyDevice
Passive recording of the head pulse
| Study group | Role | What they receive |
|---|---|---|
| MINDRHYTHM HARMONY | Passive Recording of the head pulse Receives: Device: Harmony |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®.
The subject's final discharge diagnosis based on the CTA scan and the neurologist's assessment will serve as the "ground truth" diagnosis. The sensitivity and specificity will be estimated as the point estimate (Harmony® identified correctly divided by the ground truth number); the confidence intervals will be estimated by the Clopper-Pearson method (exact intervals for proportions).
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start15 Jun 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MindRhythm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wayne State University
- Responsible party
- Sponsor
- Investigators
- James Paxton, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602740
- Sponsor's protocol ID
- EPISODE_VS
- Acronym
- EPISODE_VS
- Status last verified
- Jun 2023
- First submitted
- 27 Oct 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x.
PubMed 31591693
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study
- ClinicalTrials.gov ID
- NCT05602740
- Acronym / sponsor ID
- EPISODE_VS / EPISODE_VS
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- MindRhythm, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Wayne State University
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 2 Nov 2022 (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.
Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.
Detailed description
Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MINDRHYTHM HARMONY | – | Device: HarmonyPassive Recording of the head pulse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are being evaluated in the prehospital environment by Paramedics/EMTs in whom stroke is suspected.
Key inclusion criteria (1 listed)
- suspected stroke in the prehospital setting
Key exclusion criteria (4 listed)
- scalp laceration
- Patient refusal
- Prisoner, other vulnerable population
- Prehospital provider feels that the recording may interfere with care
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 |
|---|---|---|
| HarmonyPassive recording of the head pulse | Device | MINDRHYTHM HARMONY |
Primary outcome
The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®.
Time frame: Through study completion, an average of 6 months
The subject's final discharge diagnosis based on the CTA scan and the neurologist's assessment will serve as the "ground truth" diagnosis. The sensitivity and specificity will be estimated as the point estimate (Harmony® identified correctly divided by the ground truth number); the confidence intervals will be estimated by the Clopper-Pearson method (exact intervals for proportions).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 31591693Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x.
- Individual participant dataSharing planned: No
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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.
James Paxton, MD principal investigator
Wayne State University
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 Stroke, Acute, run by MindRhythm, Inc. 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 1 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: status not confirmed, as of the sponsor's last update on 28 Jul 2023. 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?
Results are not available in the source record.
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?
The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®. (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602740, which also lists 1 linked publication.
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 28 Jul 2023.