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

NCT00718497 | Completed

• 1 other identifier: Internal-17018
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Disease; Motor Neuron Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time Taken to Complete a Sentence

  1 session

Study Arms (1)

ALS

Subjects having either definite or probable ALS by El Escorial Criteria.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS clinic patients at MDA/ALS Center of Hope.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Drexel University College of Medicine: lead
• MDA/ALS Center of Hope: collaborator

Study Sites (1)

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Motor Neuron Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Terry Heiman-Patterson, MD

  MDA/ALS Center of Hope

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 18, 2008
• Study Start: August 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

US (1)