- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02980380
Brain Computer Interface Complete locked-in State Communication
Brain Computer Interface Based Communication in the Completely Locked-In State
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ujwal Chaudhary, PhD
- Email: ujwal.chaudhary@uni-tuebingen.de
Study Contact Backup
- Name: Niels Birbaumer, PhD
- Email: niels.birbaumer@uni-tuebingen.de
Study Locations
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Baden Wuerttemberg
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Tubingen, Baden Wuerttemberg, Germany, 72076
- Recruiting
- University of Tuebingen
-
Contact:
- Niels Birbaumer, PhD
- Email: niels.birbaumer@uni-tuebingen.de
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Contact:
- Ujwal Chaudhary, PhD
- Email: ujwal.chaudhary@uni-tuebinge.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Amyotrophic lateral sclerosis patients without any eye movement
Exclusion Criteria:
- Amyotrophic lateral sclerosis patients with intact eye movement
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Niels Birbaumer, PhD, University Hospital Tuebingen
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALS BCI study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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