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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.
U.S. Department of Education
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan Identifier:
First received: May 5, 2010
Last updated: June 10, 2015
Last verified: June 2015
People 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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A P300 Brain Computer Interface Keyboard to Control Assistive Technology for People With Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

Further study details as provided by Jane Huggins, PhD, University of Michigan:

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

    Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.

    Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.

Enrollment: 13
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P300 Brain Computer Interface for people with ALS 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.
Other Name: Electrode cap made by Electro-cap International.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01119001

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

Additional Information:
Responsible Party: Jane Huggins, PhD, Research Assistant Professor, University of Michigan Identifier: NCT01119001     History of Changes
Other Study ID Numbers: H0004
Study First Received: May 5, 2010
Results First Received: May 27, 2015
Last Updated: June 10, 2015

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases processed this record on September 21, 2017