N/A N=20 Diagnostic

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

Consciousness Disorders · Locked-In Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02772302 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Apr 2021

Primary outcome: Primary: Behavioral Diagnosis of Level of Consciousness (LoC) — 0; 23; 2; 23 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: mindBEAGLE EEG-based brain-computer interface (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Behavioral Diagnosis of Level of Consciousness (LoC)	0; 23; 2; 23; 2; 23	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02772302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.