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Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome

NCT02772302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-03

Study results available
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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.

Conditions

  • Consciousness Disorders
  • Locked-In Syndrome

Interventions

DEVICE

mindBEAGLE EEG-based brain-computer interface

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Brian L. Edlow, M.D. · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2019-12-01
Completion
2019-12-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02772302 on ClinicalTrials.gov