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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00718497
Other study ID # Internal-17018
Secondary ID
Status Completed
Phase N/A
First received July 14, 2008
Last updated March 1, 2013
Start date August 2007
Est. completion date May 2012

Study information

Verified date March 2013
Source Drexel University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 89 Years
Eligibility 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)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Locations

Country Name City State
United States MDA/ALS Center of Hope Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Drexel University College of Medicine MDA/ALS Center of Hope

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time Taken to Complete a Sentence 1 session No
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