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Assessment of the Cyberlink Control System for Use by the Amyotrophic Lateral Sclerosis (ALS) Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00718016
Recruitment Status : Terminated (New protocol was developed based on preliminary results from this study.)
First Posted : July 18, 2008
Last Update Posted : March 5, 2013
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )

Tracking Information
First Submitted Date July 14, 2008
First Posted Date July 18, 2008
Last Update Posted Date March 5, 2013
Study Start Date December 2004
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2013)
Usability of the Cyberlink System [ Time Frame: 4 1-hr sessions ]
Reliability and accuracy of the Cyberlink System at the end of the 4th session will be used to assess overall usability of the system
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of the Cyberlink Control System for Use by the Amyotrophic Lateral Sclerosis (ALS) Patient
Official Title Assessment of the Cyberlink Control System for Use by the ALS Patient
Brief Summary The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to operate their computers with only the use of facial, brainwave, and eye movements. This study is intended to evaluate both the complexity of the system and the degree to which complications of ALS (such as severity of involuntary movements) may interfere with the use of cyberlink.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ALS clinic patients at MDA/ALS Center of Hope.
Condition
  • Amyotrophic Lateral Sclerosis
  • Neurodegenerative Disease
  • Motor Neuron Disease
Intervention Not Provided
Study Groups/Cohorts ALS
Subjects having either definite or probable ALS by El Escorial Criteria.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 1, 2013)
1
Original Estimated Enrollment
 (submitted: July 16, 2008)
25
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Those aged 18-75 diagnosed with probable or definite ALS.

Exclusion Criteria:

  • Those with decision impairment will not be considered.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00718016
Other Study ID Numbers Internal-903
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Drexel University ( Drexel University College of Medicine )
Study Sponsor Drexel University College of Medicine
Collaborators MDA/ALS Center of Hope
Investigators
Study Director: Terry Heiman-Patterson, MD MDA/ALS Center of Hope
PRS Account Drexel University
Verification Date March 2013