EEG-Based Brain-Computer Interface Project for Individuals With Amyotrophic Lateral Sclerosis (ALS)

NCT00718458 | Completed

• 1 other identifier: Internal-17016
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Disease; Motor Neuron Disease

Keywords

Amyotrophic Lateral Sclerosis; Cerebrospinal Fluid; Neurodegenerative Disease; Motor Neuron Disease; Autonomic Nervous System; Neurodegenerative Diseases; Movement Disorders

Outcome Measures

Primary Outcomes (1)

• BCI Accuracy

  Measurement of percent spelling accuracy of the BCI system will be a main factor in determining usability of the system.

  1 session

Study Arms (2)

ALS

Subjects having either definite or probable ALS by El Escorial Criteria.

Non-ALS

Subjects not having either definite or probable ALS by El Escorial Criteria.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS clinic patients at MDA/ALS Center of Hope.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Drexel University College of Medicine: lead
• MDA/ALS Center of Hope: collaborator

Study Sites (1)

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Motor Neuron Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Terry Heiman-Patterson, MD

  MDA/ALS Center of Hope

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 18, 2008
• Study Start: August 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)