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NCT02791425 · ClinicalTrials.gov registry record · NA
Brain Computer Interface for Communication in Ventilated Patients
A NA study, sponsored by University of Michigan.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT02791425 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 1 participants.
The verdict
NCT02791425, a NA study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Objectives: Specific Aim 1: To demonstrate the feasibility of using a Steady State Visual Evoked Potential (SSVEP) based Brain Computer Interface (BCI) device to facilitate communication of common patient needs in alert mechanically ventilated patients in the Intensive Care Unit (ICU). Specific Aim 2: To determine patient, family and bedside nurse satisfaction with communication using the BCI device and elicit open-ended feedback to guide future device improvements Design: Translational pilot study of a Steady State Visual Evoked Potential (SSVEP) based BCI system to facilitate communication in intubated patients, with sequential use of the BCI device and a picture board. Selection of the primary self-identified primary patient need on the BCI device will be compared to the icon selected on the picture board (reference standard). A patient satisfaction survey will then be provided to the patient or a family member following use for 2 hours a day for 3 consecutive days. Primary outcome: Accurate selection of the illustrative icon on the brain computer interface representing the physical or emotional need self-identified by the patient as being the most common trigger for communication with the bedside nurse during their admission. Secondary outcome: Selection by patients or family of "agree" or "strongly agree" with the statement "The Brain computer interface device allowed me to communicate my needs to the bedside nurse adequately". Intervention: Use of the brain computer device in the ICU for communication for 2 hours a day for 3 consecutive days Control/ Comparator: Sequential use of a communication picture board for 2 hours a day for 3 consecutive days, on the same days that the BCI device is used Sample Size: 30 mechanically ventilated but alert patients in the Intensive Care Unit
Interventions
- DEVICE Brain Computer Interface (BCI) device
- OTHER Communication picture board
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2017-08-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02791425
The ClinicalTrials.gov registry entry for NCT02791425 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Brain Computer Interface (BCI) device is the first listed.
NCT02791425 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02791425 about?
NCT02791425 is a clinical study titled "Brain Computer Interface for Communication in Ventilated Patients". Objectives: Specific Aim 1: To demonstrate the feasibility of using a Steady State Visual Evoked Potential (SSVEP) based Brain Computer Interface (BCI) device to facilitate communication of common patient needs in alert mechanically ventilated patients in the Intensive Care Unit (ICU). Specific Ai...
What is the current status of trial NCT02791425?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2017-03-01. Estimated completion is 2017-08-25.
What interventions are being tested in trial NCT02791425?
The interventions under investigation include: Brain Computer Interface (BCI) device (DEVICE), Communication picture board (OTHER).
Who is sponsoring clinical trial NCT02791425?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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