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

Study 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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis , Neurodegenerative Disease , Motor Neuron Disease

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Terry Heiman-Patterson, MD, MDA/ALS Center of Hope

Clinicaltrials.gov ID:

NCT00718497

Neals Affiliated?

No

Coordinating Center Contact Information

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19104 United States

Full Study 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.

Study Sponsor:

Drexel University College of Medicine

Estimated Enrollment:

25

Estimated Study Start Date:

07 / 31 / 2007

Estimated Study Completion Date:

05 / 01 / 2012

Posting Last Modified Date:

03 / 05 / 2013

Date Study Added to neals.org:

07 / 18 / 2008

Study Population
ALS clinic patients at MDA/ALS Center of Hope.

Minimum Age:

18 Years

Maximum Age:

89 Years

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)

MDA/ALS Center of Hope

Philadelphia, Pennsylvania 19107
United States