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Brain Computer Interface Complete locked-in State Communication

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ClinicalTrials.gov Identifier: NCT02980380
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ujwal Chaudhary, University Hospital Tuebingen

Tracking Information
First Submitted Date November 22, 2016
First Posted Date December 2, 2016
Last Update Posted Date April 19, 2019
Actual Study Start Date June 2014
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 29, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02980380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Computer Interface Complete locked-in State Communication
Official Title Brain Computer Interface Based Communication in the Completely Locked-In State
Brief Summary 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Amyotrophic lateral sclerosis patients in complete locked-in state without any eye movement
Condition Complete Locked-in State
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.
Study Groups/Cohorts 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.
Intervention: Other: Non-invasive brain computer interface
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 29, 2016)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Amyotrophic lateral sclerosis patients without any eye movement

Exclusion Criteria:

  • Amyotrophic lateral sclerosis patients with intact eye movement
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Ujwal Chaudhary, PhD ujwal.chaudhary@uni-tuebingen.de
Contact: Niels Birbaumer, PhD niels.birbaumer@uni-tuebingen.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02980380
Other Study ID Numbers ALS BCI study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Data will be made available to other researcher after publication of the study
Responsible Party Dr. Ujwal Chaudhary, University Hospital Tuebingen
Study Sponsor University Hospital Tuebingen
Collaborators Not Provided
Investigators
Principal Investigator: Niels Birbaumer, PhD University Hospital Tuebingen
PRS Account University Hospital Tuebingen
Verification Date April 2019