Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
This study has been completed.
Sponsor:
Drexel University College of Medicine
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00718497
First received: July 14, 2008
Last updated: March 1, 2013
Last verified: March 2013
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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.
| Condition |
|---|
|
Amyotrophic Lateral Sclerosis Neurodegenerative Disease Motor Neuron Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population |
Resource links provided by NLM:
Further study details as provided by Drexel University:
Primary Outcome Measures:
- Time Taken to Complete a Sentence [ Time Frame: 1 session ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | August 2007 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
ALS
Subjects having either definite or probable ALS by El Escorial Criteria.
|
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
ALS clinic patients at MDA/ALS Center of Hope.
Criteria
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718497
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718497
Locations
| United States, Pennsylvania | |
| MDA/ALS Center of Hope | |
| Philadelphia, Pennsylvania, United States, 19107 | |
Sponsors and Collaborators
Drexel University College of Medicine
MDA/ALS Center of Hope
Investigators
| Principal Investigator: | Terry Heiman-Patterson, MD | MDA/ALS Center of Hope |
More Information
| Responsible Party: | Drexel University College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00718497 History of Changes |
| Other Study ID Numbers: | Internal-17018 |
| Study First Received: | July 14, 2008 |
| Last Updated: | March 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Drexel University:
|
Amyotrophic Lateral Sclerosis Cerebrospinal Fluid Neurodegenerative Disease Motor Neuron Disease |
Autonomic Nervous System Neurodegenerative Diseases Movement Disorders |
Additional relevant MeSH terms:
|
Sclerosis Motor Neuron Disease Amyotrophic Lateral Sclerosis Neurodegenerative Diseases Pathologic Processes Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |
ClinicalTrials.gov processed this record on September 28, 2016