Consciousness DisordersNCT02772302

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

A study testing mindBEAGLE EEG-based brain-computer interface in people with Consciousness Disorders and Locked-In Syndrome, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Consciousness Disorders, Locked-In Syndrome
What is being tested?: mindBEAGLE EEG-based brain-computer interface
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2016to 17 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome

The primary aims of this study are:

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);
To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;
To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Read the detailed description

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;
To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Conditions: Consciousness Disorders, Locked-In Syndrome
Being tested: mindBEAGLE EEG-based brain-computer interface
Medical subject headings: Consciousness Disorders, Locked-In Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mindBEAGLE EEG-based brain-computer interfaceDevice

Study groups in NCT02772302
Study group	Role	What they receive
Patients	Experimental	Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface Receives: Device: mindBEAGLE EEG-based brain-computer interface
Healthy Controls	Experimental	Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface Receives: Device: mindBEAGLE EEG-based brain-computer interface

What is being measured

The primary outcome is the main question the study is designed to answer.

Behavioral Diagnosis of Level of Consciousness (LoC)
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.
Measured: on the day of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201617 Dec 2019

First posted13 May 2016 (estimated)
Study start1 Mar 2016
Primary completion1 Dec 2019
Study completion17 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Consciousness DisordersStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Arm 1: patients Arm 2: healthy controls
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02772302
Sponsor's protocol ID: 2015P002731
Status last verified: Jun 2021
First submitted: 30 Mar 2016
Last updated: 3 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Consciousness Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome
ClinicalTrials.gov ID: NCT02772302
Acronym / sponsor ID: 2015P002731
Conditions: Consciousness Disorders, Locked-In Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 1 Mar 2016 (actual)
Primary completion: 1 Dec 2019 (actual)
Study completion: 17 Dec 2019 (actual)
First posted: 13 May 2016 (estimated)
Results: Posted 30 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary aims of this study are:

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);
To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;
To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Detailed description

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;
To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Arm 1: patients Arm 2: healthy controls

Arm	Type	Receives
Patients	Experimental	Device: mindBEAGLE EEG-based brain-computer interfaceApplication of bedside, EEG-based mindBEAGLE Brain-Computer Interface
Healthy Controls	Experimental	Device: mindBEAGLE EEG-based brain-computer interfaceApplication of bedside, EEG-based mindBEAGLE Brain-Computer Interface

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age>18
Diagnosis of coma
Vegetative state
Minimally conscious state
Confusional state

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mindBEAGLE EEG-based brain-computer interface	Device	Healthy Controls, Patients

Primary outcome

Behavioral Diagnosis of Level of Consciousness (LoC)
Time frame: on the day of intervention
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.

Results and safety

Results posted to the registry on 30 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mindBEAGLE	10	10
Healthy Controls	10	10

Primary outcome: Behavioral Diagnosis of Level of Consciousness (LoC)

Time frame: on the day of intervention. Number. Unit: score on a scale

Measure	mindBEAGLE n = 10	Healthy Control Subjects n = 10
patient 1	0	23
patient 2	2	23
patient 3	2	23
patient 4	2	23
patient 5	5	23
patient 6	3	23
patient 7	10	23
patient 8	13	23

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

Adverse events

Time frame: During mindBEAGLE assessment in the intensive care unit, which lasted up to 4 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mindBEAGLE	1 of 10 (10%)	0 of 10 (0%)	0 of 10
Healthy Controls	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Feasibility of an EEG-based brain-computer interface in the intensive care unitLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian L. Edlow, M.D. principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing mindBEAGLE EEG-based brain-computer interface in people with Consciousness Disorders and Locked-In Syndrome, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavioral Diagnosis of Level of Consciousness (LoC) (time frame: on the day of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02772302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.