Clinical Trial: Brain Computer Interface Complete locked-in State Communication

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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 extens
Sponsor: University Hospital Tuebingen

Current Primary Outcome: Brain Computer Interface Based Communication in the Completely Locked-In State patients [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital Tuebingen

Dates:
Date Received: November 22, 2016
Date Started: June 2014
Date Completion:
Last Updated: November 29, 2016
Last Verified: November 2016