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

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ClinicalTrials.gov Identifier: NCT00718497
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : March 5, 2013
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )

Study Description
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Brief Summary:

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.


Condition or disease
Amyotrophic Lateral Sclerosis Neurodegenerative Disease Motor Neuron Disease

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
Study Start Date : August 2007
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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


Outcome Measures
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Primary Outcome Measures :
  1. Time Taken to Complete a Sentence [ Time Frame: 1 session ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 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:

  • 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)
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT00718497


Locations
United States, Pennsylvania
MDA/ALS Center of Hope
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Drexel University College of Medicine
MDA/ALS Center of Hope
Investigators
Principal Investigator: Terry Heiman-Patterson, MD MDA/ALS Center of Hope
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00718497     History of Changes
Other Study ID Numbers: Internal-17018
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