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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Drexel University
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00718458
First received: July 14, 2008
Last updated: May 1, 2014
Last verified: March 2013
  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.


Condition
Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: EEG-Based Brain-Computer Interface Project for Individuals With ALS

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • BCI Accuracy [ Time Frame: 1 session ] [ Designated as safety issue: No ]
    Measurement of percent spelling accuracy of the BCI system will be a main factor in determining usability of the system.


Estimated Enrollment: 150
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

ALS clinic patients at MDA/ALS Center of Hope.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718458

Locations
United States, Pennsylvania
MDA/ALS Center of Hope Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Christine Barr, RN    267-507-2585    cbarr@drexelmed.edu   
Principal Investigator: Terry Heiman-Patterson, MD         
Sponsors and Collaborators
Drexel University College of Medicine
MDA/ALS Center of Hope
Investigators
Principal Investigator: Terry Heiman-Patterson, MD MDA/ALS Center of Hope
  More Information

No publications provided

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT00718458     History of Changes
Other Study ID Numbers: Internal-17016
Study First Received: July 14, 2008
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Neurodegenerative Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014