500 "Normal" Adult Subjects Who Have Experienced no Known Brain Injury Will Participate in Collecting Data That Will Assist With the Optimization of the Diagnostic Capabilities of the Harmony in Detecting Neurologic Abnormalities. (REFRESH)
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ClinicalTrials.gov Identifier: NCT05203393 |
Recruitment Status :
Not yet recruiting
First Posted : January 24, 2022
Last Update Posted : November 16, 2022
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Condition or disease | Intervention/treatment |
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Cranial Waveform in Normal Patients as a Result of Cardiac Cycle Healthy | Device: Harmony Headset |
This study will involve recordings using MindRhythm's Harmony 4000, a novel, non-invasive investigative medical device. The Harmony 4000 collects accelerometry data on the motion of the skull resulting from the movement of the brain during each cardiac cycle. The motion of the skull due to brain movement is named the HeadPulse by MindRhythm. The HeadPulse, cranial accelerometry, has been shown to provide clinically relevant data for concussion, vasospasm and Large Vessel Occlusion (LVO) stroke (Wade Smith, 2015). The Harmony 4000 is a headband and is self-contained. Control of the device is provided by pushbuttons (on and off) on the headband and via an MindRhythm iPhone app. The objective of this non-significant risk (NSR) study is to collect HeadPulse waveform recordings from 500 normal subjects to be used as controls when developing algorithms for trials in stroke, concussion and other neurological conditions. The data set of normal subjects will allow evaluation of repeatability and variability of HeadPulse recordings within a subject and between subjects. Collecting un-blinded HeadPulse waveform with the Harmony 4000 from normal adult subjects including and above the ages of 18 during normal circumstances will create a comparative cohort. These normal data sets will assist in improving the diagnostic capabilities of the Harmony 4000 device in detecting neurological abnormalities including but not limitied to stroke, stroke type, and concussion. These subjects will be recorded once or multiple times as a time series covering recordings up to two years in duration. A secondary endpoint will be to determine the quality of recordings obtained when subjects are permitted to make their own recordings without supervision after iPhone app based training.
Participant's will be recruited to volunteer to provide intracranial waveform data with the understanding that they are considered "healthy" subjects. Upon downloading the iPhone MindRhythm study app, subjects will be asked a series of questions related to inclusion and exclusion criteria, and presented with a consent form that describes the study, and what will be asked of them. Upon subject's direct consent (no LARS) to participate in the study, participant will be enrolled and sent a Harmony headset kit that will include brief training instructions for both the use of the headset and the iPhone app, ECG leads and the Harmony headset. Participant will follow the instructions and provide recordings by way of the app at the same time of day and based on a specified physical position that will suggested and recorded in the app. The subject will be instructed as to how to connect the ECG leads and place the pads on the chest and abdomen. As the "Headpulse" which is the intracranial waveform detected by the Harmony headset and is as a result of the natural movement of the brain immedliately following the cardiac cycle, the ECG data must also be recorded in conjunction with the cranial readings. The subject will connect the headset to their app by way of bluetooth once a position has been chosen and leads are connected. Upon connection, the subject will maintain a still and quiet position for a period of 3 minutes while the app collects the waveform data. Upon completion of the 3 minutes, an audible chime will occur and data will stop being transmitted and recorded. The subject will then transmit that data under their patient ID number to study investigators by way of a HIPAA compliant cloud based transmission and storage system. The subject has the option to withdraw from the study at any time by way of the iPhone app and/or the PI has the option to withdraw the subject from the study.
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Non-Blinded Control Study of Healthy Adults to Investigate the Morphology of the Headpulse Waveform Under Normal Conditions |
Estimated Study Start Date : | January 15, 2023 |
Estimated Primary Completion Date : | January 15, 2023 |
Estimated Study Completion Date : | January 15, 2023 |
- Device: Harmony Headset
The Harmony headset is a non-invasive nonsignificant risk observational device to collect intracranial waveform data. The headset will be placed on "normal" study participants to collect data for a period of 3 minutes and transferred to investigators for analysis.
- Development of comparative cohort of baseline intracranial waveform data in adults with no known neurological injury. [ Time Frame: These subjects will be recorded once or multiple times as a time series covering recordings up to two years in duration. ]To collect un-blinded HeadPulse waveform with the Harmony 4000 from normal adult subjects including and above the ages of 18 during normal circumstances in order to create a comparative cohort. These normal data sets will assist in improving the diagnostic capabilities of the Harmony 4000 device in detecting neurological abnormalities.
- To collect intracranial waveform data to analyze the quality of the signal when varied individuals collect it under varied circumstances. [ Time Frame: The analysis of the quality of the data will be evaluated as the data is transmitted to the investigators over a period of 2 years during the duration of the study. ]A secondary endpoint will be to determine the quality of recordings obtained when subjects are permitted to make their own recordings without supervision after iPhone app based training.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria: Male and female adults from the age of 18 who have the ability to consent with no surrogates.
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Exclusion Criteria: Open wound to the head, pregnant women, not suitable for participation per the opinion of the PI.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05203393
Contact: Paul Lovoi, PhD | 8608368630 | Paul.Lovoi@mindrhythm.com | |
Contact: Beth Johnson | 8608368630 | Beth.Johnson@mindrhythm.com |
United States, California | |
MindRhythm Incorporated | |
Cupertino, California, United States, 95014 | |
Contact: Paul Lovoi, PhD 408-230-6396 | |
Contact: Beth Johnson 8608368630 Beth.Johnson@mindrhythm.com | |
Principal Investigator: Paul Lovoi, PhD | |
Sub-Investigator: John Keane | |
Sub-Investigator: Beth Johnson | |
Sub-Investigator: Lisa Distenfield |
Principal Investigator: | Paul Lovoi, PhD | Chief Technical Officer, MindRhythm Incorporated |
Responsible Party: | MindRhythm, Inc. |
ClinicalTrials.gov Identifier: | NCT05203393 |
Other Study ID Numbers: |
NORMAL-001MR |
First Posted: | January 24, 2022 Key Record Dates |
Last Update Posted: | November 16, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |