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
Non-Blinded Control Study of Healthy Adults to Investigate the Morphology of the Headpulse Waveform Under Normal Conditions
1 other identifier
observational
500
1 country
1
Brief Summary
The REFRESH study is designed to collect data related to a signal in the brain that MindRhythm has named the Headpulse. The Headpulse occurs as a natural movement of the brain in conjunction with the beating of the heart. 500 "normal" subjects who are considered healthy as they do not have any current known neurological injury will collect the brain signal data from the non-invasive headband style headset for a duration of 3 minutes either once or multiple times. Upon consenting to participate to the study by way of the accompanying MindRhythm app, participants will be sent a Harmony headset kit which will include ECG leads to collect cardiac data in conjunction with the brain signal. The participant will receive training materials and instructions on how to collect and transmit data to investigators by way of the MindRhythm app. The data collected by these "normal" patients will be used as a comparator to individuals who are suspected of neurological injury. This data will assist in training the data analysis algorithm to optimize its diagnostic abilities in detecting neurological injury or abnormalities including but not limited to stroke, stroke type, and concussion. The data set will also be analyzed to determine how the signal varies within an individual and amongst other "normals." An additional benefit of collecting this data will be to gain knowledge related to the ergonomic factors of the app and the headset and its "user friendliness."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
January 24, 2022
CompletedStudy Start
First participant enrolled
January 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2023
CompletedNovember 16, 2022
November 1, 2022
Same day
January 10, 2022
November 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Development of comparative cohort of baseline intracranial waveform data in adults with no known neurological injury.
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.
These subjects will be recorded once or multiple times as a time series covering recordings up to two years in duration.
Secondary Outcomes (1)
To collect intracranial waveform data to analyze the quality of the signal when varied individuals collect it under varied circumstances.
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.
Interventions
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.
Eligibility Criteria
Community sample from the United States of 500 men and women volunteers who are considered "healthy" in so much as there is no indication that participants do not have a neurological disease or condition, or related conditions or symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MindRhythm, Inc.lead
Study Sites (1)
MindRhythm Incorporated
Cupertino, California, 95014, United States
Related Publications (2)
Smith WS, Browne JL, Ko NU. Cranial Accelerometry Can Detect Cerebral Vasospasm Caused by Subarachnoid Hemorrhage. Neurocrit Care. 2015 Dec;23(3):364-9. doi: 10.1007/s12028-015-0118-9.
PMID: 25761424RESULTSmith 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.
PMID: 31591693RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Lovoi, PhD
Chief Technical Officer, MindRhythm Incorporated
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
January 24, 2022
Study Start
January 15, 2023
Primary Completion
January 15, 2023
Study Completion
January 15, 2023
Last Updated
November 16, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share