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EEG-Based Brain-Computer Interface Project for Individuals With Amyotrophic Lateral Sclerosis (ALS) (BCI)
This study is currently recruiting participants.
Verified by Drexel University, July 2008
Sponsors and Collaborators: Drexel University
MDA/ALS Center of Hope
Information provided by: Drexel University
ClinicalTrials.gov Identifier: NCT00718458
  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.


Condition
Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease

Genetics Home Reference related topics: amyotrophic lateral sclerosis familial paroxysmal nonkinesigenic dyskinesia
MedlinePlus related topics: Amyotrophic Lateral Sclerosis Degenerative Nerve Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Cross-Sectional
Official Title: EEG-Based Brain-Computer Interface Project for Individuals With ALS

Further study details as provided by Drexel University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 50
Study Start Date: August 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (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.

  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
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, 19104
Contact: Christine Barr, RN     215-762-5186     cbarr@drexelmed.edu    
Principal Investigator: Terry Heiman-Patterson, MD            
Sponsors and Collaborators
Drexel University
MDA/ALS Center of Hope
Investigators
Principal Investigator: Terry Heiman-Patterson, MD MDA/ALS Center of Hope
  More Information

Responsible Party: MDA/ALS Center of Hope ( Terry Heiman-Patterson, MD )
Study ID Numbers: Internal-17016
Study First Received: July 14, 2008
Last Updated: July 16, 2008
ClinicalTrials.gov Identifier: NCT00718458  
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

Study placed in the following topic categories:
Amyotrophic lateral sclerosis
Neuromuscular Diseases
Spinal Cord Diseases
Movement Disorders
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Lou Gehrig's disease
Sclerosis
Degenerative motor system disease
Neurodegenerative Diseases
Motor neuron disease
Motor Neuron Disease

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009