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Pilot Study of Acute Stroke Using the Brainpulse™
NCT03235271 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE BrainPulse Device
Study Locations (3)
Illinois
- Northwest Community Healthcare — Arlington Heights
- NorthShore University Health System — Evanston
Ohio
- University of Cincinnati, Department of Emergency Medicine — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2017-09-10 |
| Est. Completion | 2024-08-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03235271
The ClinicalTrials.gov registry entry for NCT03235271 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jan Medical, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Stroke, Acute appearing as the primary indexed condition, and to 1 intervention — of which BrainPulse Device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03235271 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Illinois, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03235271 about?
NCT03235271 is a clinical study titled "Pilot Study of Acute Stroke Using the Brainpulse™". 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...
What is the current status of trial NCT03235271?
This trial is currently completed. The enrollment target is 252 participants. The study started on 2017-09-10. Estimated completion is 2024-08-28.
What conditions does trial NCT03235271 study?
This clinical trial studies the following conditions: Stroke, Acute. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03235271?
The interventions under investigation include: BrainPulse Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03235271?
This trial is sponsored by Jan Medical, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03235271 being conducted?
This trial has 3 study locations across Illinois, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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