Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
Verified date | March 2013 |
Source | Drexel University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 89 Years |
Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | MDA/ALS Center of Hope | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Drexel University College of Medicine | MDA/ALS Center of Hope |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time Taken to Complete a Sentence | 1 session | No |
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