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NCT02772302 · ClinicalTrials.gov registry record · NA
Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
A NA study of Locked-in Syndrome and Consciousness Disorders, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02772302: Completed NA study of Locked-in Syndrome and Consciousness Disorders, sponsored by Massachusetts General Hospital.
NCT02772302 is a NA study of Locked-in Syndrome and Consciousness Disorders that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, above the 9-participant average among 4 other Locked-in Syndrome trials with a reported enrollment target (122% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02772302, a NA study of Locked-in Syndrome and Consciousness Disorders, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aims of this study are: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS); 2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness; 3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness; 4. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.
Primary Outcome
LoC will be defined using the Coma Recovery Scale-Revised behavioral evaluation (score range 0-23). Higher scores are generally associated with a higher level of consciousness.
Conditions Studied
Interventions
- DEVICE mindBEAGLE EEG-based brain-computer interface
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2019-12-17 |
| Phase | NA |
What the finished NCT02772302 record still lists
NCT02772302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, above the 9-participant average among 4 other Locked-in Syndrome trials with a reported enrollment target (122% higher).
The record links to 2 conditions, with Locked-in Syndrome appearing as the primary indexed condition, and to 1 intervention - of which mindBEAGLE EEG-based brain-computer interface is the first listed.
NCT02772302 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02772302 about?
NCT02772302 is a clinical study titled "Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome". The primary aims of this study are: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS); 2. To determine if mindBEAGLE neurophysiologic markers of cogn...
What is the current status of trial NCT02772302?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2016-03-01. Estimated completion is 2019-12-17.
What conditions does trial NCT02772302 study?
This clinical trial studies the following conditions: Locked-in Syndrome, Consciousness Disorders.
What interventions are being tested in trial NCT02772302?
The interventions under investigation include: mindBEAGLE EEG-based brain-computer interface (DEVICE).
Who is sponsoring clinical trial NCT02772302?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02772302 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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