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Sponsors and Collaborators: |
Drexel University MDA/ALS Center of Hope |
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Information provided by: | Drexel University |
ClinicalTrials.gov Identifier: | NCT00718458 |
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 |
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Amyotrophic Lateral Sclerosis Cerebrospinal Fluid Neurodegenerative Disease Motor Neuron Disease |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | EEG-Based Brain-Computer Interface Project for Individuals With ALS |
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 |
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ALS
Subjects having either definite or probable ALS by El Escorial Criteria.
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Non-ALS
Subjects not having either definite or probable ALS by El Escorial Criteria.
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
ALS clinic patients at MDA/ALS Center of Hope.
Inclusion Criteria:
Medical Subjects:
Healthy control subjects:
Exclusion Criteria:
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 |
Principal Investigator: | Terry Heiman-Patterson, MD | MDA/ALS Center of Hope |
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 |
Amyotrophic Lateral Sclerosis Cerebrospinal Fluid Neurodegenerative Disease Motor Neuron Disease |
Autonomic Nervous System Neurodegenerative Diseases Movement Disorders |
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 |
Pathologic Processes Nervous System Diseases |