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Assessment of the Cyberlink Control System for Use by the Amyotrophic Lateral Sclerosis (ALS) Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00718016
Recruitment Status : Terminated (New protocol was developed based on preliminary results from this study.)
First Posted : July 18, 2008
Last Update Posted : March 5, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to operate their computers with only the use of facial, brainwave, and eye movements. This study is intended to evaluate both the complexity of the system and the degree to which complications of ALS (such as severity of involuntary movements) may interfere with the use of cyberlink.

Condition or disease
Amyotrophic Lateral Sclerosis Neurodegenerative Disease Motor Neuron Disease

Study Design

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of the Cyberlink Control System for Use by the ALS Patient
Study Start Date : December 2004
Primary Completion Date : April 2009
Study Completion Date : April 2009


Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Usability of the Cyberlink System [ Time Frame: 4 1-hr sessions ]
    Reliability and accuracy of the Cyberlink System at the end of the 4th session will be used to assess overall usability of the system


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ALS clinic patients at MDA/ALS Center of Hope.
Criteria

Inclusion Criteria:

  • Those aged 18-75 diagnosed with probable or definite ALS.

Exclusion Criteria:

  • Those with decision impairment will not be considered.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718016


Locations
United States, Pennsylvania
MDA/ALS Center of Hope
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Drexel University College of Medicine
MDA/ALS Center of Hope
Investigators
Study Director: Terry Heiman-Patterson, MD MDA/ALS Center of Hope
More Information

Responsible Party: Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00718016     History of Changes
Other Study ID Numbers: Internal-903
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

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

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