Complete Locked-in StateNCT02980380
Brain Computer Interface Complete locked-in State Communication
An observational study of Complete Locked-in State, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Electroencephalography (EEG) and/or near-infrared spectroscopy (NIRS) based Brain computer interface for communication in patients without any means of communication. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complete Locked-in State
- What is being tested?
- Non-invasive brain computer interface
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Amyotrophic lateral sclerosis patients in complete locked-in state without any eye movement
Who may be able to join
- Amyotrophic lateral sclerosis patients without any eye movement
Who cannot join
- Amyotrophic lateral sclerosis patients with intact eye movement
Trial locations and contacts
1 site in 1 country.
Ujwal Chaudhary, PhD contact
Niels Birbaumer, PhD contact
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Ujwal Chaudhary, PhD, ujwal.chaudhary@uni-tuebinge.de
Niels Birbaumer, PhD, niels.birbaumer@uni-tuebingen.de
About this study
Official title: Brain Computer Interface Based Communication in the Completely Locked-In State
Electroencephalography (EEG) and/or near-infrared spectroscopy (NIRS) based Brain computer interface for communication in patients without any means of communication.
Read the 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.
- Conditions
- Complete Locked-in State
- Being tested
- Non-invasive brain computer interface
- Keywords
- non-invasive brain computer interface, communication, amyotrophic lateral sclerosis, complete locked-in state
- Medical subject headings
- Communication, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain computer interfaceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-invasive brain computer interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Computer Interface Based Communication in the Completely Locked-In State patients
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Complete Locked-in StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ujwal Chaudhary, University Hospital Tuebingen
- Investigators
- Niels Birbaumer, PhD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980380
- Sponsor's protocol ID
- ALS BCI study
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2016
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data will be made available to other researcher after publication of the study
Publications
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.
PubMed 17076808Birbaumer 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.
PubMed 10192330Birbaumer 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.
PubMed 17234696Chaudhary 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.
PubMed 25623294van 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.
PubMed 19622847Farwell 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.
PubMed 2461285Kubler 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.
PubMed 18824406De 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.
PubMed 23625062Gallegos-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.
PubMed 24789862
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface Based Communication in the Completely Locked-In State
- ClinicalTrials.gov ID
- NCT02980380
- Acronym / sponsor ID
- ALS BCI study
- Conditions
- Complete Locked-in State
- Keywords
- non-invasive brain computer interface, communication, amyotrophic lateral sclerosis, complete locked-in state
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electroencephalography (EEG) and/or near-infrared spectroscopy (NIRS) based Brain computer interface for communication in patients without any means of communication.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locked-in and complete locked-in state patients | – | Other: Non-invasive brain computer interfaceAmyotrophic 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Amyotrophic lateral sclerosis patients in complete locked-in state without any eye movement
Key inclusion criteria (1 listed)
- Amyotrophic lateral sclerosis patients without any eye movement
Key exclusion criteria (1 listed)
- Amyotrophic lateral sclerosis patients with intact eye movement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive brain computer interfaceThe 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. | Other | Locked-in and complete locked-in state patients |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: PubMed 17076808Birbaumer 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.
- Background: PubMed 10192330Birbaumer 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.
- Background: PubMed 17234696Birbaumer 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.
- Background: PubMed 25623294Chaudhary 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.
- Background: PubMed 19622847van 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.
- Background: PubMed 2461285Farwell 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.
- Background: PubMed 18824406Kubler 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.
- Background: PubMed 23625062De 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.
- Background: PubMed 24789862Gallegos-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.
- Individual participant dataSharing planned: Undecided. Data will be made available to other researcher after publication of the study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ujwal Chaudhary, PhD contact
Niels Birbaumer, PhD contact
Niels Birbaumer, PhD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complete Locked-in State, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ujwal Chaudhary, PhD (ujwal.chaudhary@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Computer Interface Based Communication in the Completely Locked-In State patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980380, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.