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

This study has been terminated.
(New protocol was developed based on preliminary results from this study.)
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00718016
First received: July 14, 2008
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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
Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of the Cyberlink Control System for Use by the ALS Patient

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Usability of the Cyberlink System [ Time Frame: 4 1-hr sessions ] [ Designated as safety issue: No ]
    Reliability and accuracy of the Cyberlink System at the end of the 4th session will be used to assess overall usability of the system


Enrollment: 1
Study Start Date: December 2004
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
ALS
Subjects having either definite or probable ALS by El Escorial Criteria.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT00718016     History of Changes
Other Study ID Numbers: Internal-903
Study First Received: July 14, 2008
Last Updated: March 1, 2013
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:
Motor Neuron Disease
Neurodegenerative Diseases
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Proteostasis Deficiencies
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on November 20, 2014