Assessment of the Cyberlink Control System for Use by the... | NCT00718016

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

NCT00718016

Sponsor

Drexel University College of Medicine

Status

Terminated

Last Update Posted

Mar 5, 2013Estimated

Enrollment

1Actual

Phase

Not provided

Conditions

Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

New protocol was developed based on preliminary results from this study.

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 16, 2008

First Posted Date

Jul 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2013

Last Update Posted Date

Mar 5, 2013Estimated

Name	Class
MDA/ALS Center of Hope	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
ALS		Subjects having either definite or probable ALS by El Escorial Criteria.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Usability of the Cyberlink System	Reliability and accuracy of the Cyberlink System at the end of the 4th session will be used to assess overall usability of the system	4 1-hr sessions

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Those with decision impairment will not be considered.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

ALS clinic patients at MDA/ALS Center of Hope.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Terry Heiman-Patterson, MD	MDA/ALS Center of Hope	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MDA/ALS Center of Hope		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D019636	Neurodegenerative Diseases
D016472	Motor Neuron Disease
D009069	Movement Disorders

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D057177	TDP-43 Proteinopathies

Browse Leaves

Not provided

Browse Branches

Not provided