<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02980380</url>
  </required_header>
  <id_info>
    <org_study_id>ALS BCI study</org_study_id>
    <nct_id>NCT02980380</nct_id>
  </id_info>
  <brief_title>Brain Computer Interface Complete locked-in State Communication</brief_title>
  <official_title>Brain Computer Interface Based Communication in the Completely Locked-In State</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electroencephalography (EEG) and/or near-infrared spectroscopy (NIRS) based Brain computer&#xD;
      interface for communication in patients without any means of communication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Amyotrophic lateral sclerosis is a progressive motor disease of unknown etiology resulting&#xD;
      eventually in a complete paralysis of the motor system but affecting sensory or cognitive&#xD;
      functions to a minor degree. There is no treatment available; patients have to decide to&#xD;
      accept artificial respiration and feeding after the disease destroys respiratory and bulbar&#xD;
      functions or to die of respiratory or related problems. If they opt for life and accept&#xD;
      artificial respiration, the disease progresses until the patient loses control of the last&#xD;
      muscular response, usually the eye muscles. If rudimentary voluntary control of at least one&#xD;
      muscle is present the syndrome is called locked-in state (LIS); ultimately as the disease&#xD;
      progresses most ALS patients lose the control of all muscles, the resulting condition is&#xD;
      called completely locked-in state (CLIS). Patients in CLIS are unable to communicate with the&#xD;
      external world because all assistive communication aids are based on some remaining motor&#xD;
      control; hence there is a vital need for an assistive technology to help patients in CLIS to&#xD;
      communicate needs and feelings to their family members/caregivers. Brain computer interface&#xD;
      (BCI) represents a promising strategy to establish communication with paralyzed ALS patients,&#xD;
      as it does not need muscle control. BCI research includes invasive (implantable electrodes on&#xD;
      or in the neocortex) and noninvasive means (including electroencephalography (EEG),&#xD;
      magnetoencephalography (MEG), functional magnetic resonance imaging (fMRI), and near-infrared&#xD;
      spectroscopy (NIRS)) to record brain activity for conveying the user's intent to devices such&#xD;
      as simple word-processing programs. Non-invasive methods have been utilized more frequently&#xD;
      than invasive methods for people with disabilities (such as those with ALS).&#xD;
&#xD;
      For these conditions (LIS and CLIS) Brain-Computer-Interface were developed and tested&#xD;
      extensively since the first publication of Birbaumer, 1999 of two LIS patients suffering from&#xD;
      ALS. Patients select letters or words after learning self-regulation of the particular brain&#xD;
      signal or by focusing their attention to the desired letter or a letter-matrix and the&#xD;
      attention related brain potential selects the desired letter.&#xD;
&#xD;
      Different types of BCI based on EEG and/NIRS is under development to provide a means of&#xD;
      communication to patients who have none.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brain Computer Interface Based Communication in the Completely Locked-In State patients</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Complete Locked-in State</condition>
  <arm_group>
    <arm_group_label>Locked-in and complete locked-in state patients</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-invasive brain computer interface</intervention_name>
    <description>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 &quot;yes&quot; and &quot;no&quot; 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.</description>
    <arm_group_label>Locked-in and complete locked-in state patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Amyotrophic lateral sclerosis patients in complete locked-in state without any eye movement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Amyotrophic lateral sclerosis patients without any eye movement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Amyotrophic lateral sclerosis patients with intact eye movement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niels Birbaumer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ujwal Chaudhary, PhD</last_name>
    <email>ujwal.chaudhary@uni-tuebingen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Niels Birbaumer, PhD</last_name>
    <email>niels.birbaumer@uni-tuebingen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Tuebingen</name>
      <address>
        <city>Tubingen</city>
        <state>Baden Wuerttemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ujwal Chaudhary, PhD</last_name>
      <email>ujwal.chaudhary@uni-tuebinge.de</email>
    </contact>
    <contact_backup>
      <last_name>Niels Birbaumer, PhD</last_name>
      <email>niels.birbaumer@uni-tuebingen.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Birbaumer N. Breaking the silence: brain-computer interfaces (BCI) for communication and motor control. Psychophysiology. 2006 Nov;43(6):517-32. doi: 10.1111/j.1469-8986.2006.00456.x.</citation>
    <PMID>17076808</PMID>
  </reference>
  <reference>
    <citation>Birbaumer N, Ghanayim N, Hinterberger T, Iversen I, Kotchoubey B, Kubler A, Perelmouter J, Taub E, Flor H. A spelling device for the paralysed. Nature. 1999 Mar 25;398(6725):297-8. doi: 10.1038/18581. No abstract available.</citation>
    <PMID>10192330</PMID>
  </reference>
  <reference>
    <citation>Birbaumer N, Cohen LG. Brain-computer interfaces: communication and restoration of movement in paralysis. J Physiol. 2007 Mar 15;579(Pt 3):621-36. doi: 10.1113/jphysiol.2006.125633. Epub 2007 Jan 18.</citation>
    <PMID>17234696</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25623294</PMID>
  </reference>
  <reference>
    <citation>van Gerven M, Farquhar J, Schaefer R, Vlek R, Geuze J, Nijholt A, Ramsey N, Haselager P, Vuurpijl L, Gielen S, Desain P. The brain-computer interface cycle. J Neural Eng. 2009 Aug;6(4):041001. doi: 10.1088/1741-2560/6/4/041001. Epub 2009 Jul 22.</citation>
    <PMID>19622847</PMID>
  </reference>
  <reference>
    <citation>Farwell LA, Donchin E. Talking off the top of your head: toward a mental prosthesis utilizing event-related brain potentials. Electroencephalogr Clin Neurophysiol. 1988 Dec;70(6):510-23. doi: 10.1016/0013-4694(88)90149-6.</citation>
    <PMID>2461285</PMID>
  </reference>
  <reference>
    <citation>Kubler A, Birbaumer N. Brain-computer interfaces and communication in paralysis: extinction of goal directed thinking in completely paralysed patients? Clin Neurophysiol. 2008 Nov;119(11):2658-66. doi: 10.1016/j.clinph.2008.06.019. Epub 2008 Sep 27.</citation>
    <PMID>18824406</PMID>
  </reference>
  <reference>
    <citation>De Massari D, Ruf CA, Furdea A, Matuz T, van der Heiden L, Halder S, Silvoni S, Birbaumer N. Brain communication in the locked-in state. Brain. 2013 Jun;136(Pt 6):1989-2000. doi: 10.1093/brain/awt102. Epub 2013 Apr 26.</citation>
    <PMID>23625062</PMID>
  </reference>
  <reference>
    <citation>Gallegos-Ayala G, Furdea A, Takano K, Ruf CA, Flor H, Birbaumer N. Brain communication in a completely locked-in patient using bedside near-infrared spectroscopy. Neurology. 2014 May 27;82(21):1930-2. doi: 10.1212/WNL.0000000000000449. Epub 2014 Apr 30.</citation>
    <PMID>24789862</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Dr. Ujwal Chaudhary</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>non-invasive brain computer interface</keyword>
  <keyword>communication</keyword>
  <keyword>amyotrophic lateral sclerosis</keyword>
  <keyword>complete locked-in state</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Locked-In Syndrome</mesh_term>
    <mesh_term>Quadriplegia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be made available to other researcher after publication of the study</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02980380
org study id: ALS BCI study
nct id: NCT02980380
lead sponsor: 
has dmc: No
Electroencephalography (EEG) and/or near-infrared spectroscopy (NIRS) based Brain computer
      interface for communication in patients without any means of communication.
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.
observational model: Case-Only
time perspective: Retrospective
measure: Brain Computer Interface Based Communication in the Completely Locked-In State patients
time frame: 2 years
description: 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.
arm group label: Locked-in and complete locked-in state patients
description: 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.
intervention type: Other
intervention name: Non-invasive brain computer interface
description: 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.
arm group label: Locked-in and complete locked-in state patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Niels Birbaumer, PhD
role: Principal Investigator
affiliation: University Hospital Tuebingen
last name: Ujwal Chaudhary, PhD
email: ujwal.chaudhary@uni-tuebingen.de
last name: Niels Birbaumer, PhD
email: niels.birbaumer@uni-tuebingen.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
citation: Birbaumer N. Breaking the silence: brain-computer interfaces (BCI) for communication and motor control. Psychophysiology. 2006 Nov;43(6):517-32. doi: 10.1111/j.1469-8986.2006.00456.x.
PMID: 17076808
citation: Birbaumer N, Ghanayim N, Hinterberger T, Iversen I, Kotchoubey B, Kubler A, Perelmouter J, Taub E, Flor H. A spelling device for the paralysed. Nature. 1999 Mar 25;398(6725):297-8. doi: 10.1038/18581. No abstract available.
PMID: 10192330
citation: Birbaumer N, Cohen LG. Brain-computer interfaces: communication and restoration of movement in paralysis. J Physiol. 2007 Mar 15;579(Pt 3):621-36. doi: 10.1113/jphysiol.2006.125633. Epub 2007 Jan 18.
PMID: 17234696
citation: 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
citation: van Gerven M, Farquhar J, Schaefer R, Vlek R, Geuze J, Nijholt A, Ramsey N, Haselager P, Vuurpijl L, Gielen S, Desain P. The brain-computer interface cycle. J Neural Eng. 2009 Aug;6(4):041001. doi: 10.1088/1741-2560/6/4/041001. Epub 2009 Jul 22.
PMID: 19622847
citation: Farwell LA, Donchin E. Talking off the top of your head: toward a mental prosthesis utilizing event-related brain potentials. Electroencephalogr Clin Neurophysiol. 1988 Dec;70(6):510-23. doi: 10.1016/0013-4694(88)90149-6.
PMID: 2461285
citation: Kubler A, Birbaumer N. Brain-computer interfaces and communication in paralysis: extinction of goal directed thinking in completely paralysed patients? Clin Neurophysiol. 2008 Nov;119(11):2658-66. doi: 10.1016/j.clinph.2008.06.019. Epub 2008 Sep 27.
PMID: 18824406
citation: De Massari D, Ruf CA, Furdea A, Matuz T, van der Heiden L, Halder S, Silvoni S, Birbaumer N. Brain communication in the locked-in state. Brain. 2013 Jun;136(Pt 6):1989-2000. doi: 10.1093/brain/awt102. Epub 2013 Apr 26.
PMID: 23625062
citation: Gallegos-Ayala G, Furdea A, Takano K, Ruf CA, Flor H, Birbaumer N. Brain communication in a completely locked-in patient using bedside near-infrared spectroscopy. Neurology. 2014 May 27;82(21):1930-2. doi: 10.1212/WNL.0000000000000449. Epub 2014 Apr 30.
PMID: 24789862
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Dr. Ujwal Chaudhary
investigator title: Principal Investigator
mesh term: Locked-In Syndrome
mesh term: Quadriplegia
sharing ipd: Undecided
ipd description: Data will be made available to other researcher after publication of the study