We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01119001
First Posted: May 7, 2010
Last Update Posted: June 12, 2015
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.
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan
Results First Submitted: May 27, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Amyotrophic Lateral Sclerosis
Intervention: Device: P300 Brain Computer Interface Keyboard

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
P300 Brain Computer Interface for People With ALS P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.

Participant Flow:   Overall Study
    P300 Brain Computer Interface for People With ALS
STARTED   13 
COMPLETED   11 
NOT COMPLETED   2 
Withdrawal by Subject                2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
P300 Brain Computer Interface for People With ALS P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.

Baseline Measures
   P300 Brain Computer Interface for People With ALS 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Years]
Mean (Full Range)
 62 
 (45 to 78) 
Gender 
[Units: Participants]
 
Female   4 
Male   7 


  Outcome Measures

1.  Primary:   Accuracy of Typing With a BCI Keyboard by ALS Patients.   [ Time Frame: 3 times over 2-4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jane Huggins
Organization: University of Michigan
phone: 734-936-7177
e-mail: janeh@umich.edu


Publications of Results:

Responsible Party: Jane Huggins, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01119001     History of Changes
Other Study ID Numbers: H0004
First Submitted: May 5, 2010
First Posted: May 7, 2010
Results First Submitted: May 27, 2015
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015