EEG-Based Brain-Computer Interface Project for Individuals With ALS

Study Purpose:

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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis , Neurodegenerative Disease , Motor Neuron Disease

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Terry Heiman-Patterson, MD, MDA/ALS Center of Hope

Clinicaltrials.gov ID:

NCT00718458

Neals Affiliated?

No

Coordinating Center Contact Information

MDA/ALS Center of Hope

219 N. Broad Street, Fl. 7
Philadelphia, Pennsylvania, 19104 United States

Full Study Summary:

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.

Study Sponsor:

Drexel University College of Medicine

Estimated Enrollment:

102

Estimated Study Start Date:

07 / 31 / 2007

Estimated Study Completion Date:

12 / 01 / 2016

Posting Last Modified Date:

03 / 30 / 2017

Date Study Added to neals.org:

07 / 18 / 2008

Study Population: ALS clinic patients at MDA/ALS Center of Hope.

https://clinicalt...CT00718458&rank=1

Minimum Age:

18 Years

Maximum Age:

90 Years

Inclusion Criteria:

Medical Subjects:

- Be able to give consent themselves or via a legally authorized representative.

- Diagnosed with a neuromuscular disease and have limited ability to communicate.

- Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones.

- Be able to understand and remember instructions concerning participation.

Healthy control subjects:

- Be able to consent to give consent themselves or via a legally authorized representative.

- Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones.

- Be able to understand and remember instructions concerning participation.

Exclusion Criteria:

- Individuals with cognitive impairments that would impact their ability to follow the instructions

MDA/ALS Center of Hope

Philadelphia, Pennsylvania 19107
United States