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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00718497

Enrollment

Registered

2008-07-18

Start date

2007-08-31

Completion date

2012-05-31

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Neurodegenerative Disease

Keywords

Amyotrophic Lateral Sclerosis, Cerebrospinal Fluid, Neurodegenerative Disease, Motor Neuron Disease, Autonomic Nervous System, Neurodegenerative Diseases, Movement Disorders

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Time Taken to Complete a Sentence	1 session

Countries

United States

Outcome results