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OpenTrials
Completed

NCT Number: NCT00718497

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Movement Disorders Nervous System Diseases Neurodegenerative Disease Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Time Taken to Complete a Sentence

    Time frame: 1 session

Sponsors and collaborators

Lead sponsor

Drexel University College of Medicine

Other

Collaborators

  • MDA/ALS Center of Hope

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2008
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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