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

NCT02772302 | Completed Results

• 1 other identifier: 2015P002731
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aims of this study are:

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

Conditions

Consciousness Disorders; Locked-In Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  on the day of intervention

Study Arms (2)

Patients

EXPERIMENTAL

Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

Device: mindBEAGLE EEG-based brain-computer interface

Healthy Controls

EXPERIMENTAL

Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

Device: mindBEAGLE EEG-based brain-computer interface

Interventions

mindBEAGLE EEG-based brain-computer interface DEVICE

Healthy Controls; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Feasibility of an EEG-based brain-computer interface in the intensive care unit

MeSH Terms

Conditions

Consciousness Disorders; Locked-In Syndrome

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Quadriplegia; Paralysis; Neuromuscular Diseases

Results Point of Contact

• Title: Brian Edlow
• Organization: Massachusetts General Hospital

bedlow@mgh.harvard.edu

6177246352

Study Officials

• Brian L. Edlow, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Neurology

Model Details: Arm 1: patients Arm 2: healthy controls

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: May 13, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 17, 2019
• Last Updated: June 3, 2021
• Results First Posted: April 30, 2021

Record last verified: 2021-06

Locations

US (1)