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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718497
• Other study ID #: Internal-17018
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: March 1, 2013
• Start date: August 2007
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Neurodegenerative Disease
• Neurodegenerative Diseases

Locations

Country	Name	City	State
United States	MDA/ALS Center of Hope	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University College of Medicine	MDA/ALS Center of Hope

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Taken to Complete a Sentence		1 session	No