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
  Purpose

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
Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Time Taken to Complete a Sentence [ Time Frame: 1 session ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (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 89 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:

  • 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
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: 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

No publications provided

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT00718497     History of Changes
Other Study ID Numbers: Internal-17018
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
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Metabolic Diseases
Sclerosis
Amyotrophic Lateral Sclerosis
Pathologic Processes
TDP-43 Proteinopathies
Proteostasis Deficiencies

ClinicalTrials.gov processed this record on September 18, 2014