Trial Outcomes & Findings for Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome (NCT NCT02772302)

NCT ID: NCT02772302

Last Updated: 2021-06-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: on the day of intervention
• Results posted on: 2021-06-03

Participant Flow

Participant milestones

Measure	mindBEAGLE Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface	Healthy Controls healthy subjects with no history of neurological disease
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	mindBEAGLE (Inpatient Participants) n=10 Participants Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface	mindBEAGLE (Healthy Controls) n=10 Participants Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface tested in healthy controls to provide baseline validation of the technology.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	56 years n=5 Participants	34 years n=7 Participants	41 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: on the day of intervention

Population: patients in the ICU (n=10) and healthy control subjects (n=10)

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.

Outcome measures

Measure	mindBEAGLE n=10 Participants Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface	Healthy Control Subjects n=10 Participants Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface
Behavioral Diagnosis of Level of Consciousness (LoC) patient 1	0 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 2	2 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 3	2 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 4	2 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 5	5 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 6	3 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 7	10 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 8	13 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 9	16 score on a scale	23 score on a scale
Behavioral Diagnosis of Level of Consciousness (LoC) patient 10	16 score on a scale	23 score on a scale

Adverse Events

mindBEAGLE

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	mindBEAGLE n=10 participants at risk Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface	Healthy Controls n=10 participants at risk healthy subjects with no history of neurological disease
General disorders Hypotension	10.0% 1/10 • During mindBEAGLE assessment in the intensive care unit, which lasted up to 4 hours. Participants with Disorders of Consciousness or Locked in Syndrome were enrolled in the Neuro-ICU where adverse events, related or unrelated to the intervention/device were systematically monitored through regular investigator assessment and regular laboratory testing.	0.00% 0/10 • During mindBEAGLE assessment in the intensive care unit, which lasted up to 4 hours. Participants with Disorders of Consciousness or Locked in Syndrome were enrolled in the Neuro-ICU where adverse events, related or unrelated to the intervention/device were systematically monitored through regular investigator assessment and regular laboratory testing.

Other adverse events

Adverse event data not reported

Additional Information

Brian Edlow

Massachusetts General Hospital

Phone: 6177246352

Email: bedlow@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place