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

• ClinicalTrials.gov Identifier: NCT00718016
• Recruitment Status: Terminated
• First Posted: July 18, 2008
• Last Update Posted: March 5, 2013
• Sponsor: Drexel University College of Medicine
• 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
• 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

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

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
• Current Responsible Party: Drexel University ( Drexel University College of Medicine )
• Original Responsible Party: Terry Heiman-Patterson, MD, MDA/ALS Center of Hope
• Current Study Sponsor: Drexel University College of Medicine
• Original Study Sponsor: Drexel University
• 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