Text Size

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
  Purpose

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.


Condition Intervention
Amyotrophic Lateral Sclerosis
 Device: P300 Brain Computer Interface Keyboard

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Accuracy of typing with a BCI keyboard by ALS patients. [ Time Frame: 3 times over 2-4 weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P300 Brain Computer Interface for ALS Patients 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119001

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
U.S. Department of Education
Investigators
Principal Investigator: Jane Huggins, PhD University of Michigan
  More Information

Additional Information:
University of Michigan Direct Brain Interface Project  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jane Huggins, PhD/Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01119001     History of Changes
Other Study ID Numbers: H0004
Study First Received: May 5, 2010
Last Updated: October 28, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013