NCT03235271Completed
Pilot Study of Acute Stroke Using the Brainpulse™
Non-Blinded Data Collection Pilot Study of Acute Stroke Using the Brainpulse™
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
The aim of this pilot study is to collect data on stroke patients and non-stroke patients or healthy volunteers using the BrainPulse Stroke Monitor. Subject characteristics, diagnostic procedures and clinical outcomes will be documented as part of the data collected to assess the clinical utility of the BrainPulse device. All eligible patients and healthy volunteers will be enrolled and assigned to a study Group based on confirmation of their diagnosis: Acute Ischemic Stroke, Hemorrhagic Stroke, Transient Ischemic Attack or No Stroke. The data collected from the BrainPulse will be compared across the different study groups in an attempt to distinguish stroke from other non-stroke conditions that present with similar symptoms and LVO from non-LVO types of strokes. Further assessments will also be made to evaluate if the BrainPulse can identify the presence of stroke.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 252 (actual)
- First submitted
- 28 Jul 2017
- Start date
- 10 Sept 2017
- Primary completion date
- 28 Aug 2024
- Lead sponsor
- Jan Medical, Inc.
- Diseases
- Stroke
- NCT number
- NCT03235271
What you commit to
- Study type: Observational
- Participants enrolled: 252
- From 10 Sept 2017 to the primary completion date, 28 Aug 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
Other
- Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA) (n/a for Group D2)
- Patient meets the hospital criteria for brain death
- Wound or laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
- Symptoms due to head trauma
- IV tPA commenced or completed \> 4 hours ago
- Any neuro-intervention commenced or completed between admission and time of enrollment
- If does not satisfy the eligibility criteria for groups A, B, C, and D.
Who the study is looking for
- Male or female subjects 18 years or older
- Patient undergoes or will undergo radiological imaging (CT/MR) as part of stroke evaluation (n/a for Group D2)
- Demonstrated at least 1 of the following symptoms (n/a for Group D2):
- Hemiparesis, monoparesis, or quadriparesis
- Hemisensory deficits
- Monocular/binocular visual loss
- Visual field deficits
- Diplopia
- Dysarthria
- Facial droop
- Ataxia
- Vertigo
- Aphasia
- Severe and sudden onset of headache
- Nausea, and/or vomiting
- Dizziness
- Altered or loss of consciousness
- Imbalance/ Incoordination
- Last known normal or actual time point, whichever is known, since commencement of symptoms \< 48 hours prior to enrollment (n/a for Group D2)
- Consent procedures followed per applicable IRB approvals at site
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwest Community Healthcare Coordinator of this site? Confirm its status | Arlington Heights | United States | Unknown status |
| University of Cincinnati, Department of Emergency Medicine Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Northshore University Health System Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.