Brain Computer Interface for Communication in Ventilated Patients

NCT02791425 | Terminated

• 1 other identifier: HUM00100788
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Specific Aim 1: To demonstrate the feasibility of using a Steady State Visual Evoked Potential (SSVEP) based Brain Computer Interface (BCI) device to facilitate communication of common patient needs in alert mechanically ventilated patients in the Intensive Care Unit (ICU). Specific Aim 2: To determine patient, family and bedside nurse satisfaction with communication using the BCI device and elicit open-ended feedback to guide future device improvements Design: Translational pilot study of a Steady State Visual Evoked Potential (SSVEP) based BCI system to facilitate communication in intubated patients, with sequential use of the BCI device and a picture board. Selection of the primary self-identified primary patient need on the BCI device will be compared to the icon selected on the picture board (reference standard). A patient satisfaction survey will then be provided to the patient or a family member following use for 2 hours a day for 3 consecutive days. Primary outcome: Accurate selection of the illustrative icon on the brain computer interface representing the physical or emotional need self-identified by the patient as being the most common trigger for communication with the bedside nurse during their admission. Secondary outcome: Selection by patients or family of "agree" or "strongly agree" with the statement "The Brain computer interface device allowed me to communicate my needs to the bedside nurse adequately". Intervention: Use of the brain computer device in the ICU for communication for 2 hours a day for 3 consecutive days Control/ Comparator: Sequential use of a communication picture board for 2 hours a day for 3 consecutive days, on the same days that the BCI device is used Sample Size: 30 mechanically ventilated but alert patients in the Intensive Care Unit

Conditions

Mechanical Ventilation; Nonverbal Communication; Intratracheal Intubation; Critical Illness

Keywords

Brain-Computer Interface; Intratracheal intubation; Mechanical ventilation; Nonverbal communication; Critical illness; Electroencephalography; Visual Evoked Potential

Outcome Measures

Primary Outcomes (1)

• BCI device accuracy

  Accurate selection of the illustrative icon on the brain computer interface representing the physical or emotional need self-identified by the patient as being the most common trigger for communication with the bedside nurse during their admission.

  Immediately following enrollment

Secondary Outcomes (1)

• Satisfaction survey

  At the end of 3 days of using BCI device

Study Arms (1)

Brain Computer Interface (BCI) device

EXPERIMENTAL

The patient uses the Brain Computer Interface (BCI) device in the ICU for communication for 2 hours a day for 3 consecutive days. The patient then uses a communication picture board for 2 hours a day for 3 consecutive days on the same days that the BCI device is used for comparison.

Device: Brain Computer Interface (BCI) device; Other: Communication picture board

Interventions

Brain Computer Interface (BCI) device DEVICE

A BCI system to facilitate communication in intubated patients. Patients use the device in the ICU for communication for 2 hours a day for 3 consecutive days.

Brain Computer Interface (BCI) device

Communication picture board OTHER

The patient then uses a communication picture board for 2 hours a day for 3 consecutive days on the same days that the BCI device is used for comparison.

Brain Computer Interface (BCI) device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to an Intensive Care Unit and on mechanical ventilation for at least 24 hours
• Age 18 years or older
• Able to briskly follow commands
• Unimpaired use of at least one upper limb

You may not qualify if:

• Ongoing respiratory distress, severe pain or other source of obvious discomfort requiring immediate medical or nursing attention
• Severe hemodynamic instability with ongoing need for vasopressor titration or resuscitation
• Known impairment of vision, other than error of refraction with corrective lenses present
• Inability to tolerate interruption of sedation
• Inability to communicate fluently in English
• Need for ongoing EEG monitoring

Sponsors & Collaborators

• University of Michigan: lead
• Michigan Institute for Clinical and Health Research (MICHR): collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (19)

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  PMID: 21362711 BACKGROUND

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  PMID: 2403412 BACKGROUND

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  PMID: 8705084 BACKGROUND

• Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. doi: 10.1186/cc3729. Epub 2005 Jun 1.

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  PMID: 15454792 BACKGROUND

• Maringelli F, Brienza N, Scorrano F, Grasso F, Gregoretti C. Gaze-controlled, computer-assisted communication in Intensive Care Unit: "speaking through the eyes". Minerva Anestesiol. 2013 Feb;79(2):165-75. Epub 2012 Nov 22.

  PMID: 23174919 BACKGROUND

• Smith E, Delargy M. Locked-in syndrome. BMJ. 2005 Feb 19;330(7488):406-9. doi: 10.1136/bmj.330.7488.406. No abstract available.

  PMID: 15718541 BACKGROUND

• Daly JJ, Huggins JE. Brain-computer interface: current and emerging rehabilitation applications. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S1-7. doi: 10.1016/j.apmr.2015.01.007.

  PMID: 25721542 BACKGROUND

• Chaudhary U, Birbaumer N, Curado MR. Brain-machine interface (BMI) in paralysis. Ann Phys Rehabil Med. 2015 Feb;58(1):9-13. doi: 10.1016/j.rehab.2014.11.002. Epub 2015 Jan 8.

  PMID: 25623294 BACKGROUND

• Nijboer F, Sellers EW, Mellinger J, Jordan MA, Matuz T, Furdea A, Halder S, Mochty U, Krusienski DJ, Vaughan TM, Wolpaw JR, Birbaumer N, Kubler A. A P300-based brain-computer interface for people with amyotrophic lateral sclerosis. Clin Neurophysiol. 2008 Aug;119(8):1909-1916. doi: 10.1016/j.clinph.2008.03.034. Epub 2008 Jun 20.

  PMID: 18571984 BACKGROUND

• Sellers EW, Ryan DB, Hauser CK. Noninvasive brain-computer interface enables communication after brainstem stroke. Sci Transl Med. 2014 Oct 8;6(257):257re7. doi: 10.1126/scitranslmed.3007801.

  PMID: 25298323 BACKGROUND

• Marchetti M, Priftis K. Brain-computer interfaces in amyotrophic lateral sclerosis: A metanalysis. Clin Neurophysiol. 2015 Jun;126(6):1255-1263. doi: 10.1016/j.clinph.2014.09.017. Epub 2014 Oct 2.

  PMID: 25449558 BACKGROUND

• Lesenfants D, Habbal D, Lugo Z, Lebeau M, Horki P, Amico E, Pokorny C, Gomez F, Soddu A, Muller-Putz G, Laureys S, Noirhomme Q. An independent SSVEP-based brain-computer interface in locked-in syndrome. J Neural Eng. 2014 Jun;11(3):035002. doi: 10.1088/1741-2560/11/3/035002. Epub 2014 May 19.

  PMID: 24838215 BACKGROUND

• Muller-Putz GR, Scherer R, Brauneis C, Pfurtscheller G. Steady-state visual evoked potential (SSVEP)-based communication: impact of harmonic frequency components. J Neural Eng. 2005 Dec;2(4):123-30. doi: 10.1088/1741-2560/2/4/008. Epub 2005 Oct 25.

  PMID: 16317236 BACKGROUND

• Herrmann CS. Human EEG responses to 1-100 Hz flicker: resonance phenomena in visual cortex and their potential correlation to cognitive phenomena. Exp Brain Res. 2001 Apr;137(3-4):346-53. doi: 10.1007/s002210100682.

  PMID: 11355381 BACKGROUND

• Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.

  PMID: 23269131 BACKGROUND

• Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.

  PMID: 11730446 BACKGROUND

• Brunner P, Bianchi L, Guger C, Cincotti F, Schalk G. Current trends in hardware and software for brain-computer interfaces (BCIs). J Neural Eng. 2011 Apr;8(2):025001. doi: 10.1088/1741-2560/8/2/025001. Epub 2011 Mar 24.

  PMID: 21436536 BACKGROUND

Related Links

• A practical VEP-based brain-computer interface
• BCIBench: A Benchmarking Suite for EEG-based Brain Computer Interface, ODES-11 2014 Workshop on Optimizations for DSP and Embedded Systems, February 15, 2014, Orlando, FL
• A Novel Stimulation for Multi-Class SSVEP-Based Brain-Computer Interface Using Patterns of Time-Varying Frequencies, International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), August 26-30, 2014, Chicago, IL
• Frequency recognition based on canonical correlation analysis for SSVEP-based BCIs

MeSH Terms

Conditions

Nonverbal Communication; Critical Illness

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Communication; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Omid Dehzanghi, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Neurosurgery and Neurology Medical Director, Neurointensive Care

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 6, 2016
• Study Start: March 1, 2017
• Primary Completion: August 25, 2017
• Study Completion: August 25, 2017
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)