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Brain Computer Interface Complete locked-in State Communication

This study is currently recruiting participants.
Verified November 2016 by Dr. Ujwal Chaudhary, University Hospital Tuebingen
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980380
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Ujwal Chaudhary, University Hospital Tuebingen
  Purpose
Despite partial success, communication has remained impossible for persons suffering from complete motor paralysis but intact cognitive and emotional processing, a state called complete locked-in state (CLIS).Very recently NIRS was successfully used to investigate the functional activations in the cortex of a CLIS patient in response to auditorily presented stimuli containing correct or incorrect statements and open questions. The hemodynamic change in the motor cortex of the CLIS patient was recorded across many sessions spread over more than a year and was used to train a classifier to predict the "yes" and "no" answering pattern of the CLIS patient who was previously trained to use an electroencephalography (EEG) based brain computer interface (BCI) without success. The trained classifier was able to provide online feedback ("your answer was classified as (in) correct") to the patient with performance rate of 71.76%. This is the first carefully documented case of communication in a CLIS patient with BCI, which holds promise and raises the hope for communication in CLIS. Hence, to further validate the preliminary findings of our lab and refine the technology of functional near infrared spectroscopy (fNIRS)-based BCI for communication in CLIS-patients extensive studies will be carried out on CLIS patients using fNIRS based BCIs.

Condition Intervention
Complete Locked-in State Other: Non-invasive brain computer interface

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Brain Computer Interface Based Communication in the Completely Locked-In State

Resource links provided by NLM:


Further study details as provided by Dr. Ujwal Chaudhary, University Hospital Tuebingen:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 15
Study Start Date: June 2014
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Complete locked-in state patients
Amyotrophic lateral sclerosis patients in 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

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. While healthy people and ALS patients up to the LIS showed successful EEG-BCI control and communication, completely paralyzed ALS patients in CLIS did not learn sufficient EEG-based BCI control for brain communication. A single case report by Gallegos Ayala et al., 2014 for the first time described a CLIS patient with ALS achieving BCI-control and "yes" - "no" communication to simple questions with known positive answers or negative answers and some open questions over an extensive time period. NIRS was used to measure and classify cortical oxygenation and deoxygenation following the questions. The BCI methodology used in this report departed radically from the previous BCI-procedures: a more "reflexive" mode based on learning principles of classical conditioning to simple questions was used. This "reflexive" mode served to train the classifier separating "yes" and "no" brain answers silently imagined by the patient instead of neuroelectric recording (EEG), functional NIRS (fNIRS) was used.

Gallegos Ayala et al., 2014 was the first single case report of auditory BCI control by an ALS patient in CLIS and to this date no study has reported the successful "yes"- "no" communication in several ALS patient in CLIS. In order to replicate and generalize the results of Gallegos-Ayala et al., 2014 in the present study 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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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
Contact: Ujwal Chaudhary, PhD ujwal.chaudhary@uni-tuebingen.de
Contact: Niels Birbaumer, PhD niels.birbaumer@uni-tuebingen.de

Locations
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
Principal Investigator: Niels Birbaumer, PhD University Hospital Tuebingen
  More Information

Publications:

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 Submitted: November 22, 2016
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: November 2016
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:
Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms