EEG-Based Brain-Computer Interface Project for Individuals With Amyotrophic Lateral Sclerosis (ALS) (BCI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00718458|
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : March 30, 2017
Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular condition characterized by weakness, muscle wasting, fasciculations and increased reflexes. Depending on the site of onset, individuals with ALS progressively lose control of their skeletal muscles; bulbar or the extremities. As symptoms worsen and spread, muscle atrophy becomes apparent and upper motor neuron symptoms such as spasticity complicate gait (in lower limb involvement) and manual dexterity (in upper limb involvement). The patients progress to a state of profound disability and have great difficulty in communicating; some may even be entirely "locked in" to their bodies. The capacity for simple communication could greatly improve their quality of life.
New technologies are giving people with disabilities alternate communication and control options. One such instrument is the EEG-based Brain-Computer Interface (BCI) which can provide both communication and control functions to those who have lost muscle control. By recording electroencephalographic (EEG) signals or brain waves from the scalp and then decoding them, the Wadsworth BCI allows people to make selections on a computer screen [i] In this study we will be investigating the feasibility of using EEG-based Brain-Computer Interface technology as a communication solution for individuals with ALS. The specific question addressed will be: Can individuals with ALS use the BCI for communication when they present with extreme loss of neuromuscular control and severe communication impairments? The goal of the project is to determine whether this device is a practical and realistic means for individuals with ALS to communicate. The study is intended to evaluate both the complexity of the system and the degree to which each participant will be able to communicate. Trials will consist of asking the subject to follow a series of simple instructions and complete certain tasks while using the BCI.
This study design requires that the individual live in the Philadelphia region. Please contact the Wadsworth Center of the New York State Department of Health and State University of New York at Albany directly if you reside outside of this area.
|Condition or disease|
|Amyotrophic Lateral Sclerosis Neurodegenerative Disease Motor Neuron Disease|
|Study Type :||Observational|
|Actual Enrollment :||102 participants|
|Official Title:||EEG-Based Brain-Computer Interface Project for Individuals With ALS|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Subjects having either definite or probable ALS by El Escorial Criteria.
Subjects not having either definite or probable ALS by El Escorial Criteria.
- BCI Accuracy [ Time Frame: 1 session ]Measurement of percent spelling accuracy of the BCI system will be a main factor in determining usability of the system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718458
|United States, Pennsylvania|
|MDA/ALS Center of Hope|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Terry Heiman-Patterson, MD||MDA/ALS Center of Hope|