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Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population

This study has been completed.
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00718497
First received: July 14, 2008
Last updated: March 1, 2013
Last verified: March 2013
History of Changes

July 14, 2008
March 1, 2013
August 2007
May 2012   (final data collection date for primary outcome measure)
Time Taken to Complete a Sentence [ Time Frame: 1 session ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00718497 on ClinicalTrials.gov Archive Site
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Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population

New technologies are giving people with motor disabilities alternative communication and control channels. The investigators are interested in using the Cyberlink Control System as a hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS). The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye movements.

The benefit of this study may be of substantial value to many people with severe motor impairment. Additionally, it is hoped that some of the study subjects may benefit by incorporating hands-free computer use into their daily lives.

This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily communication compared to the standard manual letter board.
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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

ALS clinic patients at MDA/ALS Center of Hope.
  • Amyotrophic Lateral Sclerosis
  • Neurodegenerative Disease
  • Motor Neuron Disease
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ALS
Subjects having either definite or probable ALS by El Escorial Criteria.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of definite or possible ALS by the El Escorial Criteria
  • Between ages of 18 to 89 years.
  • Scored two or less in the ALS FRS category 1 (Speech)
  • Scored two or less in the ALS FRS category 4 (Handwriting)
  • Cognitively intact with no other neurological diseases
  • No unstable medical problems

Exclusion Criteria:

  • Any subject not meeting the inclusion criteria
  • Patients unable to give informed consent either themselves or via a legally authorized personnel.
  • Patients diagnosed with neurological problems other than ALS (upon examination by the principal investigator)
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00718497
Internal-17018
No
Drexel University ( Drexel University College of Medicine )
Drexel University College of Medicine
MDA/ALS Center of Hope
Principal Investigator: Terry Heiman-Patterson, MD MDA/ALS Center of Hope
Drexel University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP