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

Completed

• Conditions: Neurodegenerative Disease; Amyotrophic Lateral Sclerosis; Motor Neuron Disease

• Registration Number: NCT00718497
• Lead Sponsor: Drexel University College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time Taken to Complete a Sentence	1 session

Trial Locations

Locations (1)

MDA/ALS Center of Hope; 🇺🇸 Philadelphia, Pennsylvania, United States