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

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Mass General Brigham

Status

Completed

Conditions

Locked-In Syndrome
Consciousness Disorders

Treatments

Device: mindBEAGLE EEG-based brain-computer interface

Study type

Interventional

Funder types

Other

Identifiers

NCT02772302
2015P002731

Details and patient eligibility

About

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.

Full description

  1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Neurosciences Intensive Care Unit in patients with DOC or LIS;
  2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
  3. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age>18
  • Diagnosis of coma
  • Vegetative state
  • Minimally conscious state
  • Confusional state
  • Locked-in state

Exclusion criteria

• History of developmental, neurologic, or major psychiatric disorder resulting in functional disability

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Patients
Experimental group
Description:
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
Treatment:
Device: mindBEAGLE EEG-based brain-computer interface
Healthy Controls
Experimental group
Description:
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
Treatment:
Device: mindBEAGLE EEG-based brain-computer interface

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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