Brain Computer Interface Complete locked-in State Communication

Complete Locked-in State Clinical Trial

Official title:

Brain Computer Interface Based Communication in the Completely Locked-In State

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02980380
• Other study ID #: ALS BCI study
• Status: Recruiting
• Start date: June 2014
• Est. completion date: April 2022

Study information

• Verified date: April 2019
• Source: University Hospital Tuebingen
• Contact: Ujwal Chaudhary, PhD
• Email: ujwal.chaudhary[@]uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Amyotrophic lateral sclerosis patients without any eye movement

Exclusion Criteria:

• Amyotrophic lateral sclerosis patients with intact eye movement

Related Conditions & MeSH terms

• Complete Locked-in State
• Quadriplegia

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Tuebingen	Tubingen	Baden Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (9)

Birbaumer N, Cohen LG. Brain-computer interfaces: communication and restoration of movement in paralysis. J Physiol. 2007 Mar 15;579(Pt 3):621-36. Epub 2007 Jan 18. Review. — View Citation

Birbaumer N, Ghanayim N, Hinterberger T, Iversen I, Kotchoubey B, Kübler A, Perelmouter J, Taub E, Flor H. A spelling device for the paralysed. Nature. 1999 Mar 25;398(6725):297-8. — View Citation

Birbaumer N. Breaking the silence: brain-computer interfaces (BCI) for communication and motor control. Psychophysiology. 2006 Nov;43(6):517-32. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Kübler 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years