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Brain Computer Interface Complete locked-in State Communication

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ClinicalTrials.gov Identifier: NCT02980380
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ujwal Chaudhary, University Hospital Tuebingen

Brief Summary:
Electroencephalography (EEG) and/or near-infrared spectroscopy (NIRS) based Brain computer interface for communication in patients without any means of communication.

Condition or disease Intervention/treatment
Complete Locked-in State Other: Non-invasive brain computer interface

Detailed Description:

Amyotrophic lateral sclerosis is a progressive motor disease of unknown etiology resulting eventually in a complete paralysis of the motor system but affecting sensory or cognitive functions to a minor degree. There is no treatment available; patients have to decide to accept artificial respiration and feeding after the disease destroys respiratory and bulbar functions or to die of respiratory or related problems. If they opt for life and accept artificial respiration, the disease progresses until the patient loses control of the last muscular response, usually the eye muscles. If rudimentary voluntary control of at least one muscle is present the syndrome is called locked-in state (LIS); ultimately as the disease progresses most ALS patients lose the control of all muscles, the resulting condition is called completely locked-in state (CLIS). Patients in CLIS are unable to communicate with the external world because all assistive communication aids are based on some remaining motor control; hence there is a vital need for an assistive technology to help patients in CLIS to communicate needs and feelings to their family members/caregivers. Brain computer interface (BCI) represents a promising strategy to establish communication with paralyzed ALS patients, as it does not need muscle control. BCI research includes invasive (implantable electrodes on or in the neocortex) and noninvasive means (including electroencephalography (EEG), magnetoencephalography (MEG), functional magnetic resonance imaging (fMRI), and near-infrared spectroscopy (NIRS)) to record brain activity for conveying the user's intent to devices such as simple word-processing programs. Non-invasive methods have been utilized more frequently than invasive methods for people with disabilities (such as those with ALS).

For these conditions (LIS and CLIS) Brain-Computer-Interface were developed and tested extensively since the first publication of Birbaumer, 1999 of two LIS patients suffering from ALS. Patients select letters or words after learning self-regulation of the particular brain signal or by focusing their attention to the desired letter or a letter-matrix and the attention related brain potential selects the desired letter.

Different types of BCI based on EEG and/NIRS is under development to provide a means of communication to patients who have none.


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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Brain Computer Interface Based Communication in the Completely Locked-In State
Actual Study Start Date : June 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Locked-in and complete locked-in state patients
Amyotrophic lateral sclerosis patients in complete locked-in state as well as in transition from locked-in to complete locked-in state who have no means of communication.
Other: Non-invasive brain computer interface
The hemodynamic change in the motor cortex of the CLIS patient will be recorded across many sessions spread over more than a year and will be used to train a classifier to predict the "yes" and "no" answering pattern of the CLIS patient. For patient who can still open their eyes but cannot use any other means of communication will control an EEG based BCI for communication.




Primary Outcome Measures :
  1. Brain Computer Interface Based Communication in the Completely Locked-In State patients [ Time Frame: 2 years ]
    fNIRS based BCI will be employed for communication in ALS patients in CLIS. The hemodynamic change in the motor cortex of the CLIS patient will be recorded and will be used for communication.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Amyotrophic lateral sclerosis patients in complete locked-in state without any eye movement
Criteria

Inclusion Criteria:

  • Amyotrophic lateral sclerosis patients without any eye movement

Exclusion Criteria:

  • Amyotrophic lateral sclerosis patients with intact eye movement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980380


Contacts
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Contact: Ujwal Chaudhary, PhD ujwal.chaudhary@uni-tuebingen.de
Contact: Niels Birbaumer, PhD niels.birbaumer@uni-tuebingen.de

Locations
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Germany
University of Tuebingen Recruiting
Tubingen, Baden Wuerttemberg, Germany, 72076
Contact: Ujwal Chaudhary, PhD       ujwal.chaudhary@uni-tuebinge.de   
Contact: Niels Birbaumer, PhD       niels.birbaumer@uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Niels Birbaumer, PhD University Hospital Tuebingen

Publications:

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Responsible Party: Dr. Ujwal Chaudhary, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02980380     History of Changes
Other Study ID Numbers: ALS BCI study
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be made available to other researcher after publication of the study
Keywords provided by Dr. Ujwal Chaudhary, University Hospital Tuebingen:
non-invasive brain computer interface
communication
amyotrophic lateral sclerosis
complete locked-in state
Additional relevant MeSH terms:
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Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms