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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • MDA/ALS Center of Hope

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ALS clinic patients at MDA/ALS Center of Hope.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ALS; Subjects having either definite or probable ALS by El Escorial Criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time Taken to Complete a Sentence	1 session

Collaborators and Investigators

• Sponsor: Drexel University College of Medicine
• Collaborators: MDA/ALS Center of Hope
• Investigators: Principal Investigator: Terry Heiman-Patterson, MD, MDA/ALS Center of Hope

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Estimate): March 5, 2013
• Last Update Submitted That Met QC Criteria: March 1, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Autonomic Nervous System; Neurodegenerative Disease; Movement Disorders; Neurodegenerative Diseases; Cerebrospinal Fluid
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases
• Other Study ID Numbers: Internal-17018