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

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01119001
First received: May 5, 2010
Last updated: October 28, 2010
Last verified: January 2010
History of Changes

May 5, 2010
October 28, 2010
February 2010
October 2010   (final data collection date for primary outcome measure)
Accuracy of typing with a BCI keyboard by ALS patients. [ Time Frame: 3 times over 2-4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01119001 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis
A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis

Patients with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer interface (BCI) keyboard to type in assistive technology devices. The results of this study will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Amyotrophic Lateral Sclerosis
Device: 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.
Experimental: P300 Brain Computer Interface for ALS Patients
Intervention: Device: P300 Brain Computer Interface Keyboard
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 or older.
  • Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities
  • Able to see the BCI display
  • Able to give informed consent
  • Able to understand and remember instructions concerning participation
  • Able to communicate effectively at least with familiar conversation partners

Exclusion Criteria:

  • Are unable to give informed consent.
  • Are currently experiencing open head sores
  • Have a history of photo-sensitive epilepsy
  • Have a history of cognitive deficits requiring accommodation or special education services
  • Are unable to sit without moving the head and neck for at least 15 minutes
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01119001
H0004
No
Jane Huggins, PhD/Research Assistant Professor, University of Michigan
University of Michigan
U.S. Department of Education
Principal Investigator: Jane Huggins, PhD University of Michigan
University of Michigan
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP